Recalls / —
—#28846
Product
Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
- FDA product code
- MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Device class
- Class 3
- Medical specialty
- Unknown
- Affected 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
Why it was recalled
Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
Root cause (FDA determination)
Other
Action the firm took
Distributors returned thier stock after May 8, 2003
Recalling firm
- Firm
- Wright Medical Technology Inc
- Address
- 5677 Airline Rd P.O. Box 100, Arlington, Tennessee 38002
Distribution
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2003-08-18
- Posted by FDA
- 2003-08-28
- Terminated
- 2004-01-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #28846. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.