Recall Z-1554-2008 ยท FZW Expander, Surgical, Skin Graft
Zimmer Inc.
Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7708-000-10. Single use device for use during skin grafting procedures.
| Date | Jul 30, 2008 (initiated Apr 3, 2008) |
| Status | Terminated |
| Reason | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| Root cause | Packaging process control |
| Action | 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. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.