Home › Device types › FZW
Expander, Surgical, Skin Graft
FDA product code FZW · Class 1 · General, Plastic Surgery
86
Registered devices
5,240
Adverse events
9
Recalls
8
510(k) clearances
Devices with this code
MeshgraftTM II Tissue Expansion System — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.MT — JIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.Sterilisation container for Mesher — Nouvag AGSwann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDMeshgraft skin expansion system — Nouvag AGSwann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITED4Med — 4 MED LTDMESHGRAFT™ — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHIntegra® Padgett® Dermatomes — INTEGRA LIFESCIENCES CORPORATIONN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Motiva® Inflatable Balloon — Establishment Labs S.A.MT — JIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHMotiva® Inflatable Balloon — Establishment Labs S.A.Arthrex® — ARTHREX, INC.Swann Morton Ltd. — SWANN-MORTON LIMITEDIntegra® Padgett® — INTEGRA LIFESCIENCES CORPORATIONN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-02 | Zimmer Surgical Inc | 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 addition |
| 2017-04-24 | Molnlycke Health Care, Inc | Sterilization validation failure. |
| 2010-01-29 | Linvatec Corp. dba ConMed Linvatec | There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
| 2008-04-03 | Zimmer Inc. | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
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