Expander, Surgical, Skin Graft
FDA adverse event reports and recall history for expander, surgical, skin graft (product code FZW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,199
- Deaths
- 0
- Injuries
- 265
- Malfunctions
- 4,931
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-02-13Open, ClassifiedUnder Investigation by firm
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
- 2017-05-03Open, ClassifiedProcess design
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Sterilization validation failure.
- 2010-09-28TerminatedProcess control
CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
- 2008-07-30TerminatedPackaging process control
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.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- 2008-07-30TerminatedPackaging process control
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.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- 2008-07-30TerminatedPackaging process control
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.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- 2008-07-30TerminatedPackaging process control
Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-015-00. Single use device for use during skin grafting procedures.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- 2008-07-30TerminatedPackaging process control
Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7708-000-10. Single use device for use during skin grafting procedures.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
- 2008-07-30TerminatedPackaging process control
Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7716-000-10. Single use device for use during skin grafting procedures.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
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