FDA Device

Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00. Single use device for use during skin grafting procedures.

Hazard

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

What You Should Do

Remedy

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.

Products

Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00. Single use device for use during skin grafting procedures.
Brand
Zimmer Inc.
UPC
All lots.

Units Affected

99345 of all units