Expander, Surgical, Skin Graft
FDA product code FZW · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
8510(k) clearances
0PMA approvals
9recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080158 | LB Medical Inflatable Tissue Elevator/Expander SystemFZW · Traditional | Lb Medical LLC | 05/02/2008SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | Wells Johnson Co. | 01/28/1999SE |
| K972109 | Spacemaker Surgicalballoon Dissector/ExpanderFZW · Traditional | General Surgical Innovations | 11/14/1997SE |
| K936186 | Aesculap Skin Graft MesherFZW · Traditional | Aesculap, Inc. | 03/10/1994SE |
| K904265 | Inamed Ruiz-Cohen Intraoperative Tissue ExpanderFZW · Traditional | Inamed Development Co. | 03/06/1991SE |
| K902349 | Surgitek Intra-Span Intraoperative Tissue ExpanderFZW · Traditional | Surgitek | 09/05/1990SE |
| K883303 | Mentor Rapid-Span (TM) Tissue ExpanderFZW · Traditional | Mentor Corp. | 08/26/1988SE |
| K874276 | Cui, Versafil(Tm), Ste(Tm) Tissue ExpanderFZW · Traditional | Cox-Uphuff Intl. | 12/02/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1078-2024 Class II | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrierDue to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The… | Zimmer Surgical Inc | 01/02/2024Open, Classified |
| Z-2110-2017 Class II | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'Sterilization validation failure. | Molnlycke Health Care, Inc | 04/24/2017Open, Classified |
| Z-2585-2010 | CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In…There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to… | Linvatec Corp. dba ConMed Linvatec | 01/29/2010Terminated |
| Z-1555-2008 | Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |
| Z-1554-2008 | Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |
| Z-1553-2008 | Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |
| Z-1552-2008 | Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |
| Z-1551-2008 | Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |
| Z-1550-2008 | Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free…Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the… | Zimmer Inc. | 04/03/2008Terminated |