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RAZEK EQUIPAMENTOS

RAZEK EQUIPAMENTOS LTDA · Model 742460200 · UDI-DI 07908882881164

NBH
2
510(k) clearances
5,126
Adverse events
55
Recalls
296
Facilities

Description

Mini Grasping Forceps 2mm (R070) - 130mm

Recalls

DateFirmReason
2020-09-21Smith & Nephew, Inc.The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system
2019-06-25BioPro, Inc.Manufacturing flaw in the sterile barrier system

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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.