—#69671

Product

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 product code: FZW — Expander, Surgical, Skin Graft
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: All lots.

Why it was recalled

Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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.

Timeline

Recall initiated: 2008-04-03
Posted by FDA: 2008-07-30
Terminated: 2009-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69671. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.