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MEDLINE RENEWAL

MEDLINE INDUSTRIES, INC. · Model 012405R · UDI-DI 10888277371897

NBH Prescription

510(k) clearances

5,221

Adverse events

Recalls

296

Facilities

Description

012405 @UNV CAN, W/OBTURATOR & TROCAR (B

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.