Recall Z-1555-2008
Zimmer Inc. · initiated April 3, 2008
Product
Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7716-000-10. Single use device for use during skin grafting procedures.
Codes / lots: All lots.
Reason for recall
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
FDA-determined cause: Packaging process control
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.
Details
- Recall number
- Z-1555-2008
- Initiated
- April 3, 2008
- Posted by FDA
- July 30, 2008
- Terminated
- December 17, 2009
- Product code
- FZW – Expander, Surgical, Skin Graft
- Quantity
- 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, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru…
- Recalling firm
- Zimmer Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1550-2008 | Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | 04/03/2008Terminated |
| Z-1551-2008 | Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | 04/03/2008Terminated |
| Z-1552-2008 | Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | 04/03/2008Terminated |
| Z-1553-2008 | Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | 04/03/2008Terminated |
| Z-1554-2008 | Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | 04/03/2008Terminated |