Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive p
FDA device recall Z-0792-06 · posted 2006-04-26 · Terminated
Recall details
- Recalling firm
- Synthes (USA)
- Reason for recall
- Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
- Action taken
- Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 3511
- Distribution
- Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United St
- Date initiated
- 2006-03-30
- Date posted
- 2006-04-26
- Date terminated
- 2006-09-20
- Location
- West Chester, PA
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