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Millennium

Avalign Technologies, Inc. · Model 72-2407035 · UDI-DI 00190776404635

NBH

510(k) clearances

5,126

Adverse events

Recalls

296

Facilities

Description

5mm, 9 1/4" wl, vats/mis elmed suture catcher/puller w/round handle, 13 3/4" ol

Recalls

Date	Firm	Reason
2020-09-21	Smith & 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.
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, Inc.	Manufacturing flaw in the sterile barrier system
2019-06-25	BioPro, 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.