Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.
This recall has been terminated (originally issued June 7, 2007).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- March 27, 2007
- Posted
- June 7, 2007
- Terminated
- June 30, 2008
- Recall Number
- Z-0868-2007
- Quantity
- 4 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The titanium plasma coating was found to have missing fragments.
Distribution
Nationwide, Puerto Rico, & Japan
Lot / Code Info
Lot No. W09350601
Root 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.
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