Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
This recall has been terminated (originally issued August 28, 2003).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- August 18, 2003
- Posted
- August 28, 2003
- Terminated
- January 29, 2004
- Recall Number
- Z-1186-03
- Quantity
- 133 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
Distribution
nationwide
Lot / Code Info
Part No. Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884
Root Cause
Other
Action Taken
Distributors returned thier stock after May 8, 2003