FDA Device Recall Z-0026-2016: Ortho Solutions Inc 330 Franklin Tnpk

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-2016.

Recall Res Number

Z-0026-2016

Recalling Firm / Manufacturer

Ortho Solutions Inc 330 Franklin Tnpk

FEI Number

3022270316

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-07-14

Date Posted

2015-10-06

Date Terminated

2017-04-26

Product Code

HWC

Event Number

71899

Product Quantity

875 units

Product Description Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

Reason for Recall Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

Action Details The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.

Distribution Pattern US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.

Code Information / Serial Numbers Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)

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BODYCAD LABORATORIES, INC. Registration: 3012086398 View Registration
SI-TECHNOLOGY, LLC Registration: 3012103114 View Registration
MicroPort Orthopedics Global Supply Center Limited Registration: 3012130008 View Registration
CURITEVA, INC. Registration: 3012131184 View Registration
ALEVIO, LLC Registration: 3012249461 View Registration
MARLE FINISHING SAS Registration: 3012275107 View Registration
ORTOSISTEMAS, S.A. Registration: 3012329552 View Registration
Arthrocare Corporation Registration: 3012358417 View Registration
XENIX MEDICAL Registration: 3012429289 View Registration
Highridge Medical, LLC Registration: 3012447612 View Registration
Arthrex Japan G.K. (Shinjuku) Registration: 3012470322 View Registration
GRAMERCY EXTREMITY ORTHOPEDICS, LLC. Registration: 3012478585 View Registration
Summit Orthopedic Technologies Inc. Registration: 3012491394 View Registration
DECOMICRO SAS Registration: 3012599928 View Registration
ZIBO DANTE CO, LTD Registration: 3012711663 View Registration
ORTHOPEDIC GENERATIONS LLC Registration: 3012724179 View Registration
Ortho Solutions Sdn Bhd Registration: 3012755988 View Registration
Device Innovation Company Limited Registration: 3012818475 View Registration
CROSMED S.A. Registration: 3012883081 View Registration
Tyber Medical Registration: 3012966183 View Registration
MAHE MEDICAL USA Registration: 3013011598 View Registration
Stryker Anngrove Registration: 3013014058 View Registration
Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA. Registration: 3013086329 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
ARMBRUSTER GMBH Registration: 3013194153 View Registration
ARVATO Netherlands B.V. Registration: 3013302242 View Registration
FUSION ORTHOPEDICS USA, LLC Registration: 3013365802 View Registration
DIAMOND ORTHOPEDIC Registration: 3013540005 View Registration
3D-SIDE Registration: 3013561205 View Registration
Autocam Medical Devices (Suzhou) Co. Ltd. Registration: 3013564228 View Registration
WISHBONE MEDICAL INC. Registration: 3013680140 View Registration
Arthrex Korea Ltd. Registration: 3013700547 View Registration
GM DOS REIS INDUSTRIA E COMERCIO LTDA Registration: 3013756169 View Registration
TRANSMEDIC HEALTHCARE SDN BHD Registration: 3013767421 View Registration
Precision Edge Surgical Products Co LLC Registration: 3013820441 View Registration
BEIJING AK MEDICAL CO, LTD Registration: 3013843055 View Registration
ORTHO MAX INC Registration: 3013843230 View Registration
GREENS SURGICALS PRIVATE LIMITED Registration: 3013846070 View Registration
Arthrex Singapore Pte Ltd. Registration: 3014004349 View Registration
STABILIZ ORTHOPAEDICS Registration: 3014104093 View Registration
GENERAL MACHINE, INC. Registration: 3014128887 View Registration
Maestro Logistics, LLC Registration: 3014129047 View Registration
PRECISION ADM Registration: 3014162916 View Registration
3D INSTRUMENTATION SDN BHD Registration: 3014170143 View Registration
Ascension Orthopedics, Inc. Registration: 3014207283 View Registration
Aju Medical Co., Ltd. Registration: 3014232239 View Registration
TDM CO.,LTD Registration: 3014257776 View Registration
Arthrex (Shanghai) Co., Ltd. Registration: 3014262693 View Registration
PRECISION MEDICAL TECHNOLOGIES Registration: 3014273424 View Registration
Tangible Solutions, Inc. DBA Marle Tangible, Inc. Registration: 3014273501 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Aristotech Industries GmbH Registration: 3014314623 View Registration
Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration
Suzhou Ahno Medical Devices Co., Ltd. Registration: 3014315669 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
KLS MARTIN MANUFACTURING, LLC Registration: 3014483751 View Registration
Summa Orthopaedics Inc. Registration: 3014522470 View Registration
QUADM TECHNOLOGIES, LLC Registration: 3014527928 View Registration
OSSIO LTD. Registration: 3014554088 View Registration
b-ONE Medical (Beijing) Co., Ltd. Registration: 3014644608 View Registration
MIRUS, LLC Registration: 3014655115 View Registration
ABLE MEDICAL DEVICES Registration: 3014680795 View Registration
Signature Orthopaedics Europe Ltd Registration: 3014763043 View Registration
JEIL MEDICAL CORPORATION Registration: 3014937101 View Registration
GLW, Inc. Registration: 3014967149 View Registration
ORTHOXEL Registration: 3014976005 View Registration
TIGON MEDICAL LLC Registration: 3015075784 View Registration
FIELD ORTHOPAEDICS Registration: 3015131017 View Registration
BOULDER BIOMED LLC Registration: 3015151147 View Registration
B-ONE MEDICAL (SUZHOU) CO., LTD. Registration: 3015167917 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
RESPONSIVE ARTHROSCOPY Registration: 3015200759 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Jabil Inc. (Brandywine) Registration: 3015212339 View Registration
STERIGENICS UK LIMITED Registration: 3015219237 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
B-ONE ORTHO, CORP. Registration: 3015259876 View Registration
SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP. Registration: 3015356625 View Registration
Kyocera Medical Technologies, Inc. Registration: 3015398319 View Registration
Jabil Inc. (Monument) Registration: 3015399803 View Registration
Jabil Inc. (Wilson Drive) Registration: 3015410662 View Registration
Jabil Inc. (Elmira) Registration: 3015440604 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Depuy Ireland UC Registration: 3015516266 View Registration
Medtronic Neurosurgery Registration: 3015531529 View Registration
JOINSMART BIOMEDICAL CO., LTD. Registration: 3015539532 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
CONEXTIONS INC Registration: 3015718210 View Registration
LifeNet Health Registration: 3015724777 View Registration
ARCTIC BIOMATERIALS OY Registration: 3015780293 View Registration
I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration
Jabil Switzerland Manufacturing GmbH (Le Locle) Registration: 3015831087 View Registration
Jabil Switzerland Manufacturing GmbH (Raron) Registration: 3015869121 View Registration
Jabil Switzerland Manufacturing GmbH (Grenchen) Registration: 3015869492 View Registration
Jabil Switzerland Manufacturing GmbH (Mezzovico) Registration: 3015869493 View Registration
Jabil Switzerland Manufacturing GmbH (Hagendorf) Registration: 3015876273 View Registration
Jabil Switzerland Manufacturing GmbH (Balsthal) Registration: 3015877656 View Registration
Jabil Switzerland Manufacturing GmbH (Bettlach) Registration: 3015882686 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
ORTHONOVIS, INC. Registration: 3015946784 View Registration
Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda Registration: 3015974593 View Registration
Olive Branch Distribution Center Registration: 3016050940 View Registration
MOUNT MFG Registration: 3016084569 View Registration
MAINSTREAM MEDICAL DEVICES Registration: 3016112537 View Registration
PTUMEDICAL GMBH Registration: 3016237080 View Registration
AVANTI ORTHOPAEDICS LLC Registration: 3016247852 View Registration
GUARDIAN MEDICAL USA, INC Registration: 3016261131 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
CURVAFIX, INC. Registration: 3016537375 View Registration
SUBCHONDRAL SOLUTIONS Registration: 3016660811 View Registration
BRM EXTREMITIES SRL Registration: 3016669046 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY Registration: 3016727307 View Registration
CB ENTERPRISES Registration: 3016759112 View Registration
NETBIOLOGICS LLC Registration: 3016778139 View Registration
AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP Registration: 3016844398 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
RETROFIX SCREWS, LLC Registration: 3017075357 View Registration
KINGJ MEDICAL CO., LTD Registration: 3017191784 View Registration
BRDH Registration: 3017196117 View Registration
NEBULA SURGICAL PRIVATE LIMITED Registration: 3017209758 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
ARTFX MEDICAL LLC Registration: 3017435639 View Registration
Jabil Tuttlingen Manufacturing GmbH Registration: 3017521423 View Registration
Elite Medical, LLC Registration: 3017528621 View Registration
Elite Medical, LLC Registration: 3017565094 View Registration
Watershed Idea Foundry, Inc. Registration: 3017597868 View Registration
Precision One Medical Registration: 3017980266 View Registration
Tyber Medical Registration: 3017980495 View Registration
LEITH MEDICAL LLC Registration: 3018077525 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
ORTHO-MED, INC. Registration: 3019455 View Registration
BRANCH MEDICAL GROUP Registration: 3019767615 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
FUSION INNOVATIONS Registration: 3019923333 View Registration
CROSSROADS EXTREMITY SYSTEMS LLC Registration: 3020584246 View Registration
Arthrex New Zealand Limited Registration: 3020704423 View Registration
Transmedic Philippines Inc. Registration: 3020899789 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
BONEBRIDGE AG Registration: 3021010222 View Registration
Arthrex Colombia SAS Registration: 3021226419 View Registration
BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration
BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
SI-BONE, INC. Registration: 3021948057 View Registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 3022132808 View Registration
Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration
INFIGO MEDICAL Registration: 3022159082 View Registration
AMNOVIS BV Registration: 3022295665 View Registration
SURGICAL FUSION INC. Registration: 3022472578 View Registration
SURGICAL FUSION TECHNOLOGIES GmbH Registration: 3022518322 View Registration
INNOVATE ORTHOPAEDICS LTD. Registration: 3022520753 View Registration
FIXIER S.A. DE C.V. Registration: 3022777867 View Registration
VOOM MEDICAL DEVICES, LLC Registration: 3022928161 View Registration
OAKTREE ADDITIVE Registration: 3023189283 View Registration
PHEN'X TECHNOLOGIES Registration: 3023265483 View Registration
ENSINGER COMPOSITES MACHINING SP. Z O.O. Registration: 3023272531 View Registration
HANGZHOU SINO-MIM TECHNOLOGY CO., LTD. Registration: 3023808054 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
SCHULER PRAEZISIONSTECHNIK KG Registration: 3024813436 View Registration
RELJA INNOVATIONS, INC Registration: 3025114181 View Registration
ACUMED LLC Registration: 3025141 View Registration
STERICO Co., Ltd. Registration: 3025318945 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD Registration: 3026311512 View Registration
Precision Edge Surgical Products, LLC Registration: 3026576110 View Registration
TRAX SURGICAL, INC. Registration: 3026586698 View Registration
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration
Arthrex Chile SPA Registration: 3027339877 View Registration
CATHTEK LLC Registration: 3027553380 View Registration
Forma Medical, Inc. Registration: 3027760323 View Registration
ORTHO CAPE Registration: 3027827832 View Registration
Dev4 Registration: 3029894043 View Registration
KAUL MEDIZINTECHNIK GMBH Registration: 3029933740 View Registration
MIING WEI CO., LTD. Registration: 3030183061 View Registration
AUXANO MEDICAL LLC Registration: 3030271054 View Registration
Promethean Restorative Inc. Registration: 3030400539 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
SUZHOU ENDOPHIX CO., LTD. Registration: 3030514683 View Registration
MEDIWORX.ONE GMBH Registration: 3030655570 View Registration
SKY SURGICAL Registration: 3030691054 View Registration
FRUH PACKAGING INC. Registration: 3030714745 View Registration
Arthrex Logistic Center Canada Registration: 3030926959 View Registration
MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration
TDM USA INC. Registration: 3031261833 View Registration
Stryker Poland Manufacturing Sp. z o.o. Registration: 3031800723 View Registration
SportCare Registration: 3032314868 View Registration
HG MEDICAL USA, LLC Registration: 3032588003 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
MEDIFIELD MEDICAL CO., LTD. Registration: 3033519208 View Registration
SIGN Fracture Care International Registration: 3034525 View Registration
ACTIS MEDICAL Registration: 3034532468 View Registration
DePuy Synthes Sales Registration: 3034676720 View Registration
Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration
ORTHO OUTCOMES, LLC Registration: 3035373797 View Registration
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD. Registration: 3035785605 View Registration
VERITAS MEDICAL DEVICES LLC Registration: 3036042032 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
HyperFlex Medical Inc Registration: 3038503572 View Registration
Smith & Nephew, Inc. Registration: 3038503932 View Registration
Able Medical Devices Registration: 3038776593 View Registration
ASTRA ORTHOMED, INC. Registration: 3041501961 View Registration
b-ONE Ortho Corp. Registration: 3042508254 View Registration
PACE SURGICAL Registration: 3042765769 View Registration
MEDULOC Registration: 3042903229 View Registration
S2ORTHO, LLC Registration: 3043026734 View Registration
FERRY MACHINE CORPORATION Registration: 3043543260 View Registration
ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA Registration: 3043620689 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
HERMANN MEDIZINTECHNIK GMBH Registration: 8010257 View Registration
DEPUY INTL., LTD. Registration: 8010379 View Registration
GEBR. BRASSELER GMBH & CO. KG Registration: 8010468 View Registration
SUBAN Instruments Germany GmbH Registration: 8010665 View Registration
BIEDERMANN MOTECH GMBH & Co. KG Registration: 8010944 View Registration
SYNTHES GMBH / Synthes Produktions GmbH Registration: 8030965 View Registration
MAILLEFER INSTRUMENTS HOLDING SARL Registration: 8031010 View Registration
STRYKER GmbH Registration: 8031020 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
AAP IMPLANTATE AG Registration: 8043862 View Registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 8043971 View Registration
CERAMTEC GmbH Medical Products Division Registration: 8044172 View Registration
AESCULAP AG Registration: 9610612 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
STRYKER TRAUMA GMBH Registration: 9610622 View Registration
HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration
KLS Martin SE & Co. KG Registration: 9610905 View Registration
DEPUY CMW Registration: 9610921 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
RUDOLF STORZ GMBH Registration: 9611274 View Registration
KARL KLAPPENECKER GMBH & CO. KG Registration: 9611281 View Registration
FRIEDRICH DANIELS GMBH Registration: 9611390 View Registration
IN'TECH MEDICAL SAS Registration: 9611579 View Registration
CHRISTIAN DIENER GMBH Registration: 9611813 View Registration
ERCHINGER AG Registration: 9611827 View Registration
JAKUTEC MEDIZINTECHNIK GMBH & Co. KG Registration: 9612277 View Registration
ZIMMER GMBH Registration: 9613350 View Registration
SMITH & NEPHEW ORTHOPAEDICS AG Registration: 9613369 View Registration
NARANG MEDICAL, LTD. Registration: 9613910 View Registration
Corin Limited Registration: 9614209 View Registration
SPHINX TOOLS LTD Registration: 9614438 View Registration
SIGNUS MEDIZINTECHNIK GMBH Registration: 9615021 View Registration
CarboFix Orthopedics, Ltd. Registration: 9615128 View Registration
DEPUY (IRELAND) Registration: 9616671 View Registration
STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
SYNTEC SCIENTIFIC CORP. Registration: 9616944 View Registration
BIOCOMPOSITES LTD. Registration: 9617083 View Registration
SMT SCHILLING METALLTECHNIK GMBH Registration: 9680619 View Registration
ORTHOFIX SRL Registration: 9680825 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration
BHH MIKROMED Registration: 9710312 View Registration
INION OY Registration: 9710629 View Registration

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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-0026-2016

Recall Parameters & Description

Related Establishments / Registrations

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