FDA Device Recall Z-0008-2012: Osteomed, Lp 3885 Arapaho Rd Addison TX 75001

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-2012.

Recall Res Number

Z-0008-2012

Recalling Firm / Manufacturer

Osteomed, Lp 3885 Arapaho Rd Addison TX 75001

FEI Number

2027754

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-06-07

Date Posted

2011-10-04

Date Terminated

2012-12-04

Product Code

MRW

Event Number

59213

Product Quantity

20 units

Product Description OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

Reason for Recall Two of the Implant Driver Assembly tips were reported to break during surgery.

Action Details OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.

Distribution Pattern Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO

Code Information / Serial Numbers Part Number 800-1212 lot # 1038452.

Related Establishments / Registrations

Paragon Medical - Dayton Registration: 1000200989 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
SOUTHEASTERN TECHNOLOGY dba Autocam Medical Registration: 1057425 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
DEPUY SPINE, INC. Registration: 1526439 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
Tech Industries. Inc. Registration: 1528646 View Registration
WARSAW ORTHOPEDIC, INC. Registration: 1824199 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
MICROPULSE INC Registration: 1834379 View Registration
NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration
MAITLAND ENGINEERING Registration: 1835572 View Registration
BIOSEAL Registration: 2027062 View Registration
ALPHATEC SPINE, INC. Registration: 2027467 View Registration
OSTEOMED Registration: 2027754 View Registration
NUVASIVE, INC. Registration: 2031966 View Registration
Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
LOWELL,INC. Registration: 2134470 View Registration
SPINEOLOGY INC. Registration: 2135156 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
RMS CO. Registration: 2183946 View Registration
Microcision LLC Registration: 2530808 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO Registration: 2647346 View Registration
Sterigenics U.S. LLC Registration: 2953359 View Registration
Viant Fremont, Inc Registration: 2954750 View Registration
Acero Precision Registration: 3000170817 View Registration
LISI MEDICAL Remmele Registration: 3000203391 View Registration
Synthes GMBH Registration: 3000270450 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
Biomerics Alajuela Registration: 3003678543 View Registration
HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
STRYKER SPINE Registration: 3004024955 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
B & G MFG. CO. Registration: 3004188066 View Registration
LDR MEDICAL Registration: 3004788213 View Registration
SPINAL ELEMENTS, INC. Registration: 3004893332 View Registration
Xtant Medical Holdings, Inc. Registration: 3005031160 View Registration
TURNER MEDICAL INC. Registration: 3005706667 View Registration
Precision Spine, Inc. Registration: 3005739886 View Registration
Choice Spine LLC Registration: 3005819474 View Registration
SPINEFRONTIER, INC. DBA LESspine Innovations Registration: 3005977257 View Registration
Wenzel Spine Registration: 3006172536 View Registration
SpineSmith Holdings, LLC Registration: 3006404071 View Registration
ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS Registration: 3006791286 View Registration
Bradshaw Medical Inc. Registration: 3006846753 View Registration
NEURO FRANCE IMPLANTS Registration: 3007385214 View Registration
NEXXT SPINE LLC Registration: 3007922509 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
Organ Eco Tech Registration: 3008526708 View Registration
ZAVATION Registration: 3008583793 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
NUVASIVE, INC. Registration: 3009144915 View Registration
PROVIDENCE MEDICAL TECHNOLOGY, INC. Registration: 3009394448 View Registration
Sterigenics Radiation Technologies IN, Inc Registration: 3009504230 View Registration
CG MedTech USA, Inc. Registration: 3009554293 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
Elite Medical, LLC Registration: 3009882675 View Registration
Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
LISI MEDICAL REmmele Registration: 3009941480 View Registration
Mendell Registration: 3009998573 View Registration
FIRST ARTICLE INC Registration: 3010032903 View Registration
CULVER TOOL & ENGINEERING Registration: 3010047454 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
BRANCH MEDICAL GROUP Registration: 3010120104 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
SIMAGEC Registration: 3010462278 View Registration
AXIAL MEDICAL Registration: 3010863450 View Registration
SEASPINE ORTHOPEDICS CORPORATION Registration: 3012120772 View Registration
Highridge Medical, LLC Registration: 3012447612 View Registration
SURGENTEC LLC Registration: 3012495575 View Registration
Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
Safe Medical Registration: 3013548554 View Registration
ABLE MEDICAL DEVICES Registration: 3014680795 View Registration
Medtronic Medical Costa Rica S.R.L. Registration: 3014725904 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
Jabil Switzerland Manufacturing GmbH (Le Locle) Registration: 3015831087 View Registration
Olive Branch Distribution Center Registration: 3016050940 View Registration
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED Registration: 3016443334 View Registration
LINCOTEK BOLOGNA S.R.L. Registration: 3016778562 View Registration
Elite Medical, LLC Registration: 3017528621 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
BRANCH MEDICAL GROUP Registration: 3019767615 View Registration
VY SPINE, LLC Registration: 3019837678 View Registration
Alphatec Spine, Inc. Registration: 3019878714 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
ZygoFix Registration: 3031232974 View Registration
SC MEDICA Registration: 3033557813 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
CG MedTech Co., Ltd. Registration: 9617297 View Registration
STRYKER SPINE Registration: 9617544 View Registration
Gammatom S.r.l. Registration: 9681465 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-0008-2012

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer