Recall Z-0032-2009
Biomet, Inc. · initiated May 23, 2008
Product
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.
Codes / lots: Lot 440360.
Reason for recall
The component in the package is not the correct size.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0032-2009
- Initiated
- May 23, 2008
- Posted by FDA
- October 3, 2008
- Terminated
- September 22, 2009
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Quantity
- 6
- Distribution
- USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0033-2009 | Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V…The component in the package is not the correct size. | 05/23/2008Terminated |