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Millennium

Avalign Technologies, Inc. · Model 72-236133LH · UDI-DI 00190776298791

NBH Prescription
2
510(k) clearances
5,174
Adverse events
55
Recalls
297
Facilities

Description

3.4mm 125mm Aggressor Wide Jaw Punch, medium, 3.2mm bite, upbiter 3.4 forceps 15deg up, upswept shaft, 2.52mm tip profile, 3.2mm bite width, 5.05mm tip width

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.