Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-013-00. Single use device for use during skin grafting procedures.
FDA Recall Z-1551-2008 · Posted 2008-07-30
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeFZW
Date Initiated2008-04-03
Date Terminated2009-12-17
Product Quantity99345 of all units
Reason for Recall
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
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, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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