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Terminated

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.

FDA Recall Z-0032-2009 · Posted 2008-10-03

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2008-05-23
Date Terminated2009-09-22
Product Quantity6

Reason for Recall

The component in the package is not the correct size.

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013042DISCOVERY ELBOWBiomet Orthopedics, Inc. · 2001-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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