FDA Device Recall Z-0007-2013: Invuity, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2013.

Recall Res Number

Z-0007-2013

Recalling Firm / Manufacturer

Invuity, Inc.

FEI Number

3007037347

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-05-12

Date Posted

2012-10-03

Date Terminated

2013-04-23

Product Code

JOL

Event Number

62966

Product Quantity

197 devices

Product Description BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Reason for Recall Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.

Action Details Invuity sent E-mails to those locations thought to still be in possession of the old model of the device in July 2012. Distributors had been e-mailed in May 2012 to make sure that they had returned any of the device that was in stock. For questions regarding this recall call 415-655-2100.

Distribution Pattern Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.

Code Information / Serial Numbers Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.

Related Establishments / Registrations

C.R. BARD, INC. Registration: 1018233 View Registration
SMITH & NEPHEW, INC. Registration: 1020279 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) Registration: 1051594 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
BOSS INSTRUMENTS, LTD. Registration: 1056350 View Registration
DeRoyal Industries, Inc. Registration: 1060680 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
TRINITY STERILE, INC. Registration: 1123010 View Registration
MERIT MEDICAL SYSTEMS, INC Registration: 1125782 View Registration
COOPERSURGICAL, INC. Registration: 1216677 View Registration
Covidien Registration: 1219930 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
Weco Manufacturing Group-Henrietta Registration: 1315756 View Registration
HARMAC MEDICAL PRODUCTS, INC. Registration: 1317547 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
SAGE PRODUCTS LLC Registration: 1419181 View Registration
Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
DEPUY SPINE, INC. Registration: 1526439 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
UTAH MEDICAL PRODUCTS, INC. Registration: 1718873 View Registration
SONTEC INSTRUMENTS, INC. Registration: 1720747 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
MICROPULSE INC Registration: 1834379 View Registration
ASPEN SURGICAL PRODUCTS, INC. Registration: 1836161 View Registration
SABIN CORPORATION Registration: 1836564 View Registration
Cardinal Health Registration: 1921846 View Registration
STERIS Corporation Registration: 1923569 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Bausch & Lomb Incorporated Registration: 1932180 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
AXIOM MEDICAL, INC. Registration: 2020735 View Registration
NEOTECH PRODUCTS, LLC Registration: 2025917 View Registration
BIOSEAL Registration: 2027062 View Registration
ALPHATEC SPINE, INC. Registration: 2027467 View Registration
ARMM, INC. Registration: 2028523 View Registration
WESTMED, INC. Registration: 2028807 View Registration
IMPLANTECH ASSOCIATES, INC. Registration: 2028924 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
ORTHOPEDIC SCIENCES, INC Registration: 2032830 View Registration
E A BECK & CO Registration: 2080222 View Registration
SCANLAN INTERNATIONAL, INC. Registration: 2126670 View Registration
PMT CORP. Registration: 2182979 View Registration
SURGICAL TECHNOLOGIES, INC. Registration: 2183319 View Registration
ORTHOFIX US LLC Registration: 2183449 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
ETHICON, INC. Registration: 2210968 View Registration
NIKOMED U.S.A., INC. Registration: 2245574 View Registration
CHARMANT U.S.A. Registration: 2248180 View Registration
GSOURCE, LLC. Registration: 2249529 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
TEMREX CORP. Registration: 2429849 View Registration
Sklar Corporation Registration: 2431166 View Registration
MED SAVER, INC. Registration: 2529846 View Registration
XODUS MEDICAL, INC. Registration: 2530138 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
SEWOON MEDICAL CO., LTD. Registration: 3000247987 View Registration
PRODUCTOS MEXICANOS DE RESINAS SA DE CV Registration: 3001304488 View Registration
UAB INTERSURGICAL Registration: 3001313714 View Registration
TECHNIMEN SKILLERS Registration: 3001620590 View Registration
INTERSURGICAL LTD. Registration: 3002807267 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
USTOMED INSTRUMENTE GMBH & CO. KG Registration: 3002808270 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
T.A. WALTHEM & COMPANY Registration: 3003407244 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
HOSPITECH MANUFACTURING SERVICES SDN BHD Registration: 3003528228 View Registration
CANADIAN HOSPITAL SPECIALTIES LTD Registration: 3003627840 View Registration
MedSource Labs, LLC Registration: 3003674698 View Registration
HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
CHINAMED PRODUCTS (CHINA) LTD. Registration: 3003799815 View Registration
SHEFFMED LIMITED Registration: 3003836856 View Registration
BR SURGICAL LLC Registration: 3004001706 View Registration
Hangzhou Jinlin Medical Appliances Co., Ltd. Registration: 3004056932 View Registration
Cixi Qimei Combination Tool Packing Factory Registration: 3004096300 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
PRODUCTOS MEDLINE S.A. DE C.V. Registration: 3004122598 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
TIGER MEDICAL GROUP Registration: 3004488394 View Registration
TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration
ANDERSEN CALEDONIA LTD Registration: 3004530184 View Registration
WENZHOU K.L.F. MEDICAL PLASTICS CO., LTD. Registration: 3004538333 View Registration
INTEGRA LIFESCIENCES CORPORATION Registration: 3004608878 View Registration
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. Registration: 3004727093 View Registration
U.S. SURGITECH, INC. Registration: 3004777218 View Registration
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
MERLYN ASSOCIATES, INC. Registration: 3005160810 View Registration
Heuer International (A division of GST Corporation Limited) Registration: 3005273623 View Registration
Laboratorios PISA S.A. de C.V. Registration: 3005440755 View Registration
AMSINO MEDICAL (SHANGHAI) CO., LTD. Registration: 3005515211 View Registration
Ambler Surgical, LLC Registration: 3005528784 View Registration
COOK MEDICAL LLC Registration: 3005580113 View Registration
ANJI HONGDE MEDICAL PRODUCTS CO., LTD. Registration: 3005621808 View Registration
PACIFIC INSTRUMENTS INC. Registration: 3005641619 View Registration
AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration
CARDINAL HEALTH SINGAPORE 225 PTE LTD Registration: 3005674464 View Registration
ANMUTH MEDICAL INTERNATIONAL LLC Registration: 3005695838 View Registration
NINGBO SHENGYURUI MEDICAL APPLIANCE CO. Registration: 3005767446 View Registration
Jarit GmbH Registration: 3005809810 View Registration
BihlerMed, LLC Registration: 3005977121 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
FLEXICARE MEDICAL (DONGGUAN) LTD. Registration: 3006061749 View Registration
ASIA CONNECTION CO., LTD. Registration: 3006157842 View Registration
CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) Registration: 3006187135 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
SUZHOU JINGLE POLYMER MEDICAL APPARATUS CO., LTD. Registration: 3006536657 View Registration
JOYKEY INDUSTRIAL (PINGHU) LIMITED Registration: 3006542380 View Registration
STERIS Deutschland GmBh Registration: 3006554912 View Registration
Conod Medical Co.,Limited Registration: 3006673317 View Registration
Hangzhou Fushan Medical Appliance Co., Ltd. Registration: 3006787036 View Registration
HOSPITAL & HOMECARE IMP. & EXP. CO., LTD Registration: 3006897996 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
Principle & Will Biotech (Pinghu) Co., Ltd. Registration: 3006973666 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
Hayden Medical Inc Registration: 3007137643 View Registration
Smith & Nephew, Inc. Registration: 3007366790 View Registration
MOSER-BAER AG Registration: 3007441485 View Registration
PATIENT SHIELD CONCEPTS LLC Registration: 3007477849 View Registration
ADLER INSTRUMENT COMPANY Registration: 3007507973 View Registration
GCMEDICA ENTERPRISE LTD. (WUXI) Registration: 3007681502 View Registration
OBP Medical Corporation Registration: 3007789561 View Registration
HOLGER BUMUELLER LLC Registration: 3007840839 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
DTR MEDICAL LTD Registration: 3008280196 View Registration
VR MEDICAL TECHNOLOGY CO., LTD. Registration: 3008311916 View Registration
EURONDA SPA Registration: 3008494033 View Registration
SOHO MEDICAL CO., LTD. Registration: 3008676146 View Registration
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Registration: 3008693658 View Registration
SUMMIT MEDICAL LLC Registration: 3008719017 View Registration
Smith & Nephew, Inc. Registration: 3008744062 View Registration
NOVO SURGICAL, INC. Registration: 3008770252 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
AVALIGN TECHNOLOGIES, Inc. Registration: 3008864603 View Registration
MEED SKILLS SURGICAL Registration: 3008936260 View Registration
UCOMFOR MEDICAL CO., LTD. Registration: 3009104075 View Registration
SMC Costa Rica Division S.R.L. Registration: 3009327445 View Registration
Quiroproductos de Cuauhtemoc S. De R.L. de C.V. Registration: 3009750712 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
Synergy Health Ede BV Registration: 3009756327 View Registration
Modern Surgical Instruments LLC Registration: 3009822485 View Registration
Isomedix Operations Inc Registration: 3009888344 View Registration
ZHEJIANG SUNGOOD TECHNOLOGY CO.,LTD Registration: 3010032035 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
TRINITY MEDICAL DEVICES INC. Registration: 3010042047 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
PLASTICS PLUS TECHNOLOGY, INC. Registration: 3010156053 View Registration
Hebei Ruinuo Medical Instrument Co Ltd Registration: 3010160370 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
BLACHE MEDICAL GMBH & CO. KG Registration: 3010235355 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Shanghai Xodus Medical Company Limited Registration: 3010380518 View Registration
WELL LEAD MEDICAL CO. LTD Registration: 3010400865 View Registration
ENDO TECH INSTRUMENTS Registration: 3010455030 View Registration
Omnia Medical Registration: 3010560653 View Registration
NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD. Registration: 3010583519 View Registration
JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. Registration: 3010594263 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
EVONOS GMBH & CO. KG Registration: 3010726901 View Registration
Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
BABY HEALTH CARE, INC. Registration: 3011052946 View Registration
CYDONIA PHARMA SL Registration: 3011088743 View Registration
CURACO INC Registration: 3011094311 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
DGS Diagnostics Sp. z o.o Registration: 3011310592 View Registration
Nanjing J SUN Healthcare Co.,Ltd Registration: 3011529314 View Registration
MIZUHO CORPORATION Registration: 3011547624 View Registration
CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD. Registration: 3011707784 View Registration
L-D TOOL & DIE DIVISION OF MADIX ENGINEERING Registration: 3011854984 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
AMSINO MEDICAL GROUP (HK) COMPANY LIMITED Registration: 3012445205 View Registration
Highridge Medical, LLC Registration: 3012447612 View Registration
Integra Canada ULC Registration: 3012507533 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
CONOD MEDICAL CO., LTD. Registration: 3012568936 View Registration
SURGIX MEDICAL LLC Registration: 3012995405 View Registration
BONREE MEDICAL CO., LTD Registration: 3013055504 View Registration
SMD MANUFACTURING LLC Registration: 3013075752 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
Arvato SE Registration: 3013247477 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
FedEx Supply Chain, Inc. Registration: 3013403214 View Registration
HANGZHOU FORMED MEDICAL DEVICES CO., LTD. Registration: 3013412170 View Registration
Teufel & Gerlach GmbH Registration: 3013497507 View Registration
Tylenol Medical Instruments Co., Ltd. Registration: 3013513837 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
GREENS SURGICALS PRIVATE LIMITED Registration: 3013846070 View Registration
NINGBO LUKE MEDICAL DEVICES CO., LTD. Registration: 3013909820 View Registration
HITEC MEDICAL CO., LTD Registration: 3014208300 View Registration
Integra LifeSciences Production Corporation Registration: 3014334038 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
O&M Halyard, Inc. Registration: 3014421917 View Registration
SUZHOU JUNELAND MEDICAL CO., LTD. Registration: 3014457631 View Registration
NINGBO YINGMED MEDICAL INSTRUMENTS CO.,LTD. Registration: 3014610488 View Registration
Pacific Hospital Supply Co., Ltd Registration: 3014615028 View Registration
Hangzhou Primecare Medical Co.,Ltd. Registration: 3014637079 View Registration
PROSPECT LIFE SCIENCES Registration: 3014680149 View Registration
Jiangsu JianYu Health Medical Co., Ltd Registration: 3014926389 View Registration
HAEMOTRONIC DE MEXICO S DE RL Registration: 3014936217 View Registration
JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. Registration: 3015058854 View Registration
ZHEJIANG HUANYI STERILIZATION TECHNOLOGY CO., LTD Registration: 3015142721 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
Primecare Medical (Suzhou) Co.,Ltd. Registration: 3015337348 View Registration
ZIBO QICHUANG MEDICAL PRODUCTS CO.,LTD. Registration: 3015416207 View Registration
WILDmedical GmbH Registration: 3015451162 View Registration
Changzhou CareU Medical Instruments Co., Ltd. Registration: 3015479927 View Registration
GUANGZHOU NUONING MEDICAL SUPPLIES CO.,LTD Registration: 3015495690 View Registration
Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
Olive Branch Distribution Center Registration: 3016050940 View Registration
SURTEX INSTRUMENTS LTD Registration: 3016069968 View Registration
JIANGSU HANHENG MEDICAL TECHNOLOGY CO., LTD Registration: 3016159368 View Registration
HENAN YADU INDUSTRIAL CO.,LTD Registration: 3016452400 View Registration
PRABADIN CORP Registration: 3016659819 View Registration
ARROW MEDSOURCE GROUP LIMITED Registration: 3016685880 View Registration
CREATE BIOTECH CO., LTD. Registration: 3016734145 View Registration
ANJI SPENQ INDUSTRIAL CO., LTD. Registration: 3016758972 View Registration
NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD Registration: 3016763307 View Registration
UCOMFOR SCIENTIFIC CO.,LTD Registration: 3016884033 View Registration
JIANGSU RONGYE TECHNOLOGY CO.,LTD Registration: 3016884191 View Registration
TIANCK MEDICAL CO.,LTD Registration: 3016950436 View Registration
SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD. Registration: 3017079526 View Registration
ETHICON, INC. Registration: 3017102971 View Registration
GUANGDONG ECAN MEDICAL CO,LTD Registration: 3017171849 View Registration
PT. Jayamas Medica Industri Tbk Registration: 3017635043 View Registration
STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD. Registration: 3017961114 View Registration
INMED (WUXI) MEDICAL DEVICE CO.,LTD Registration: 3018074706 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
MCREAT ( GUANGZHOU ) BIO-TECH CO.,LTD Registration: 3018366470 View Registration
ORALKLEEN LLC Registration: 3018418236 View Registration
GCMEDICA ENTERPRISE LTD.(WUXI) Registration: 3018503755 View Registration
PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. Registration: 3018762668 View Registration
OBP SURGICAL CORPORATION Registration: 3019385708 View Registration
Alphatec Spine, Inc. Registration: 3019878714 View Registration
SHANGHAI LEJOY CO., LTD Registration: 3020468145 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
SUNSET HEALTHCARE SOLUTIONS Warehouse Registration: 3021244152 View Registration
ALLEVA MEDICAL DEVICES Registration: 3021767551 View Registration
Microtek Medical LLC Registration: 3021970868 View Registration
SURGIMARK, INC. Registration: 3023415 View Registration
BATTECH Registration: 3024787345 View Registration
Bothwin (Beijing) Medical Technology Co., Ltd. Registration: 3025376090 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD. Registration: 3025831202 View Registration
ALLMED MEDICAL TEXTILE CO.,LTD (VIET NAM) Registration: 3026536498 View Registration
SWIFTSURE INNOVATIONS INC. Registration: 3027150141 View Registration
ANGIPLAST PVT. LTD. Registration: 3027645738 View Registration
PLATFORM INNOVATIONS INC. Registration: 3027718328 View Registration
MEDLINE CHILE SPA Registration: 3027977504 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
SHIJIAZHUANG YUANDING MEDICAL DEVICE CO.,LTD Registration: 3030672079 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD Registration: 3031184338 View Registration
VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED Registration: 3031564283 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
ADDN SOLUTIONS GMBH & CO. KG Registration: 3033536312 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
YADU MEDICAL (HENAN) CO., LTD Registration: 3034629649 View Registration
HUZHOU JUNDA INDUSTRY CO., LTD. Registration: 3034669683 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
Smith & Nephew, Inc. Registration: 3038503932 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
BOTHWIN MEDICAL TECHNOLOGY (SG) PTE. LTD. Registration: 3042172872 View Registration
PT VITANOVA MEDICAL INDONESIA Registration: 3043606675 View Registration
ASOMEDICA CO. LTD Registration: 3043619925 View Registration
BOEN HEALTHCARE CO., LTD. Registration: 3045058049 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
e.l. zepf GmbH Registration: 8010433 View Registration
GUENTER BISSINGER MEDIZINTECHNIK GMBH Registration: 8010456 View Registration
COLTENE/WHALEDENT GMBH & CO. KG Registration: 8010629 View Registration
PETER LAZIC GMBH Registration: 8010890 View Registration
IVOR SHAW, LTD. Registration: 8021832 View Registration
FLEXICARE MEDICAL LTD. Registration: 8021995 View Registration
Industrias Apson S.A de C.V Registration: 8030607 View Registration
Westmed de Mexico, S.A de C.V Registration: 8030647 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
QSA SURGICAL (PVT) LTD. Registration: 8040233 View Registration
NORTH EOS INDUSTRIES, INC. Registration: 8043235 View Registration
CHARMANT, INC. Registration: 8043467 View Registration
REDA INSTRUMENTE GMBH Registration: 8043496 View Registration
PACIFIC HOSPITAL SUPPLY CO. LTD. Registration: 8044099 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
KARL KLAPPENECKER GMBH & CO. KG Registration: 9611281 View Registration
ILG MEDIZINTECHNIK GMBH Registration: 9611610 View Registration
ERCHINGER AG Registration: 9611827 View Registration
Cardinal Health (Kenmex Medical Specialties) Registration: 9612030 View Registration
GIMMI GMBH Registration: 9612074 View Registration
OERTEL MEDICAL GMBH Registration: 9612075 View Registration
DUFNER INSTRUMENTE GMBH Registration: 9612278 View Registration
TOWNE BROTHERS (PVT.), LTD. Registration: 9613083 View Registration
ROMSONS INTERNATIONAL Registration: 9613418 View Registration
ELMED INSTRUMENTS (PVT). LTD. Registration: 9614062 View Registration
EFINGER INSTRUMENTS GmbH & Co. KG Registration: 9615004 View Registration
INDUSTRIAS PLASTICAS MEDICAS, S.A. DE C.V. Registration: 9616083 View Registration
Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration
MIZUHO Corporation Gosen Factory Registration: 9680242 View Registration
TONTARRA MEDIZINTECHNIK GMBH Registration: 9680515 View Registration
NOUVAG AG Registration: 9680741 View Registration
Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
INTEGRA MICROFRANCE SAS Registration: 9680837 View Registration
JR MONTAGEARBEITEN Registration: 9710058 View Registration
ULTIMATE MEDICAL PRODUCTS LTD. Registration: 9710524 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0007-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer