—#146037

Product

Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

FDA product code: GEA — Cannula, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280

Why it was recalled

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Timeline

Recall initiated: 2016-04-01
Posted by FDA: 2016-05-26
Terminated: 2017-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.