Expander, Surgical, Skin Graft
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
5,240 adverse event reports on file
- Zimmer Skin Graft MesherJul 30, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00917
- ZIMMER SKIN GRAFT MESHERCOMPLE TEJul 29, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00908
- Meshgraft II Instrument OnlyJul 28, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00900
- ZIMMER SKIN GRAFT MESHERJul 22, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00878
- MESHGRAFT II INSTRUMENT ONLYJul 22, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00882
- ZIMMER SKIN GRAFT MESHERJul 21, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00868
- MESHGRAFT II INSTRUMENT ONLYJul 21, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00874
- ZIMMER SKIN GRAFT MESHERJul 20, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00860
- Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )Jul 20, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00864
- MESHGRAFT II INSTRUMENT ONLYJul 20, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00865
Event type breakdown
Recalls
9 recall events for this product code
- Zimmer Surgical IncOpen, ClassifiedFeb 13, 2024
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.
Z-1078-2024 · View FDA record ↗ - Molnlycke Health Care, IncOpen, ClassifiedMay 3, 2017
Brennen Skin Graft Mesher.
Sterilization validation failure.
Z-2110-2017 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedSep 28, 2010
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.
Z-2585-2010 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1550-2008 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-013-00.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1551-2008 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1552-2008 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-015-00.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1553-2008 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7708-000-10.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1554-2008 · View FDA record ↗ - Zimmer Inc.TerminatedJul 30, 2008
Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7716-000-10.
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
Z-1555-2008 · View FDA record ↗
Registered firms
64 firms currently registered for this product code
Nouvag Ag
GOLDACH Sankt Gallen, CH
Establishment Labs S.a.
Coyol Alajuela, CR
Sterigenics Us, Llc
Lewis Center, OH, US
Ribbel International Ltd.
SONEPAT Haryana, IN
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Teleflex Medical Llc
Morrisville, NC, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Synergy Health Ast, Srl
Alajuela, CR
Integra Canada Ulc
Oakville Ontario, CA
Arthrex Singapore Pte Ltd.
Singapore Central Singapore, SG
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Ad Supply Group Limited
London London, City of, GB
Design Standards Corp.
CHARLESTOWN, NH, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Exsurco Medical, Inc.
Wakeman, OH, US
Arthrex Distribution Hub Emea B.v.
Venlo Limburg, NL
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Sign Fracture Care International
RICHLAND, WA, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Biomet Microfixation
Jacksonville, FL, US
Jiangsu Mjd Medical Technology Co.,ltd.
TAIZHOU Jiangsu, CN
Global Biyomedikal Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi
BAHCELIEVLER Istanbul, TR
Surgicon Pvt Ltd
Sialkot Punjab, PK
Yafho Bio-technology Co., Ltd.
GUANGZHOU Guangdong, CN
510(k) clearances
8 clearances for this product code
- Lb Medical LLCMay 2, 2008
K080158 · LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
- Wells Johnson Co.Jan 28, 1999
K984448 · BIRCOLL BALLOON DISSECTOR
- General Surgical InnovationsNov 14, 1997
K972109 · SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
- Aesculap, Inc.Mar 10, 1994
K936186 · AESCULAP SKIN GRAFT MESHER
- Inamed Development Co.Mar 6, 1991
K904265 · INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
- SurgitekSep 5, 1990
K902349 · SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
- Mentor Corp.Aug 26, 1988
K883303 · MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
- Cox-Uphuff Intl.Dec 2, 1987
K874276 · CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER