Z-1550-2008

Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover...

Name: Z-1550-2008 Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover...
Creator: Zimmer Inc.
Published: 2008-04-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-04-03 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of 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... on 2008-04-03. The reason FDA records is "Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1550-2008
Status: Terminated
Initiated: 2008-04-03
Posted: 2008-07-30
Terminated: 2009-12-17
Recalling firm: Zimmer GmbH
Product: 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.
Product code: FZW Expander, Surgical, Skin Graft
Reason for recall: Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Root cause tag: packaging
FDA 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 in commerce: 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, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.
Product codes and lots: All lots.

Product code FZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)