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RZ Medizintechnik GmbH

RZ-Medizintechnik GmbH · Model 110-090-100 · UDI-DI 04049197024693

FZW Prescription
8
510(k) clearances
5,240
Adverse events
9
Recalls
65
Facilities

Description

Gabarro Skin Graft Measurer

Recalls

DateFirmReason
2024-01-02Zimmer Surgical IncDue 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 i
2017-04-24Molnlycke Health Care, IncSterilization validation failure.
2010-01-29Linvatec Corp. dba ConMed LinvatecThere is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.
2008-04-03Zimmer Inc.Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
2008-04-03Zimmer Inc.Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
2008-04-03Zimmer Inc.Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
2008-04-03Zimmer Inc.Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
2008-04-03Zimmer Inc.Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
2008-04-03Zimmer 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.