FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00. Single use device for use during skin grafting procedures.
- Recall number
- Z-1552-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00. Single use device for use during skin grafting procedures.
- Status
- Terminated
- Initiated
- 2008-04-03
- Posted
- 2008-07-30
- Terminated
- 2009-12-17
- 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, 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.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZW
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28