Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
FDA device recall Z-1186-03 · posted 2003-08-28 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
- Action taken
- Distributors returned thier stock after May 8, 2003
- Root cause
- Other
- Status
- Terminated
- Product code
- MRA
- Quantity affected
- 133 units
- Distribution
- nationwide
- Date initiated
- 2003-08-18
- Date posted
- 2003-08-28
- Date terminated
- 2004-01-29
- Location
- Arlington, TN
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