FDA Device Recall Z-0034-2022: Flower Orthopedics Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2022.

Recall Res Number

Z-0034-2022

Recalling Firm / Manufacturer

Flower Orthopedics Corporation

FEI Number

3009996260

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2021-09-03

Date Posted

N/A

Date Terminated

2022-07-28

Product Code

HRS

Event Number

88724

Product Quantity

77 kits

Product Description Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Reason for Recall Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

Action Details Coventus Flower Orthopedics issued letter dated 9/3/21 via email. Letter states reason fo recall, health risk and action to take: Check your inventory for the product listed below. Look into the see-through window in the box and determine if a CDG 200 is included. The CDG 200 resembles a pen and has a long, black handle and a silver tip. A photo of the CDG 200 is below: Next, please complete and return the attached Acknowledgement and Receipt Form by Friday, September 10, 2021. If you indicate on the form that you are in possession of an EWK 201 that is missing the CDG 200 component, Conventus Flower will ask that you return that affected kit. Conventus Flower will then send a replacement EWK 201 kit. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM

Distribution Pattern US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

Code Information / Serial Numbers Lot Number: 2104321637 Unique Identifier: 00840118112079

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NEBULA SURGICAL PRIVATE LIMITED Registration: 3017209758 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
PRIMEMED INC. Registration: 3017609305 View Registration
Precision One Medical Registration: 3017980266 View Registration
Tyber Medical Registration: 3017980495 View Registration
LEITH MEDICAL LLC Registration: 3018077525 View Registration
MAXKRON MACHINE, LLC Registration: 3018080016 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
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
ENDEAVOR ORTHOPAEDICS. LLC Registration: 3021349259 View Registration
BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration
MedCAD Registration: 3021635140 View Registration
Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration
INFIGO MEDICAL Registration: 3022159082 View Registration
FIXIER S.A. DE C.V. Registration: 3022777867 View Registration
PHEN'X TECHNOLOGIES Registration: 3023265483 View Registration
HANGZHOU SINO-MIM TECHNOLOGY CO., LTD. Registration: 3023808054 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
SCHULER PRAEZISIONSTECHNIK KG Registration: 3024813436 View Registration
Zanol GmbH Registration: 3024890263 View Registration
ACUMED LLC Registration: 3025141 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
SKELETAL DYNAMICS STRATEGIC MANUFACTURING CENTER Registration: 3026035863 View Registration
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD Registration: 3026311512 View Registration
Precision Edge Surgical Products, LLC Registration: 3026576110 View Registration
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration
Arthrex Chile SPA Registration: 3027339877 View Registration
Forma Medical, Inc. Registration: 3027760323 View Registration
KAUL MEDIZINTECHNIK GMBH Registration: 3029933740 View Registration
MIING WEI CO., LTD. Registration: 3030183061 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 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
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
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
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
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
AESCULAP AG Registration: 9610612 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
Stengelin Medical GmbH Registration: 9611278 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
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
SPHINX TOOLS LTD Registration: 9614438 View Registration
CarboFix Orthopedics, Ltd. Registration: 9615128 View Registration
LISI MEDICAL FASTENERS Registration: 9615766 View Registration
CHARLES PERY & CIE Registration: 9615800 View Registration
STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
SYNTEC SCIENTIFIC CORP. Registration: 9616944 View Registration
TONTARRA MEDIZINTECHNIK GMBH Registration: 9680515 View Registration
SMT SCHILLING METALLTECHNIK GMBH Registration: 9680619 View Registration
ORTHOFIX SRL Registration: 9680825 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration
UNITED ORTHOPEDIC CORP. Registration: 9681642 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-0034-2022

Recall Parameters & Description

Related Establishments / Registrations

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