Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-
FDA device recall Z-1554-2008 · posted 2008-07-30 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- Action taken
- Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FZW
- Quantity affected
- 99345 of all units
- Distribution
- Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany
- Date initiated
- 2008-04-03
- Date posted
- 2008-07-30
- Date terminated
- 2009-12-17
- Location
- Warsaw, IN
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