FDA Device Recall Z-0032-2009: Biomet, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2009.

Recall Res Number

Z-0032-2009

Recalling Firm / Manufacturer

Biomet, Inc.

FEI Number

1825034

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-05-23

Date Posted

2008-10-03

Date Terminated

2009-09-22

Product Code

JDC

Event Number

49465

Product Quantity

Product Description Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.

Reason for Recall The component in the package is not the correct size.

Action Details Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.

Distribution Pattern USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.

Code Information / Serial Numbers Lot 440360.

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Medical Device Recall: Z-0032-2009

Recall Parameters & Description

Related Establishments / Registrations

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