Depuy brand LCS Complete metal backed patella, cemented, STD; REF 1294-09-740.
FDA device recall Z-1028-05 · posted 2005-07-21 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Action taken
- Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- NJL
- Distribution
- Nationwide and international.
- Date initiated
- 2005-06-07
- Date posted
- 2005-07-21
- Date terminated
- 2006-05-02
- Location
- Warsaw, IN
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