Recall Z-0868-2007
Wright Medical Technology Inc · initiated March 27, 2007
Product
Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.
Codes / lots: Lot No. W09350601
Reason for recall
The titanium plasma coating was found to have missing fragments.
FDA-determined cause: Other
Action taken
The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
Details
- Recall number
- Z-0868-2007
- Initiated
- March 27, 2007
- Posted by FDA
- June 7, 2007
- Terminated
- June 30, 2008
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 4 units
- Distribution
- Nationwide, Puerto Rico, & Japan
- Recalling firm
- Wright Medical Technology Inc, Arlington, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0867-2007 | Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364…The titanium plasma coating was found to have missing fragments. | 03/27/2007Terminated |