—#146050

Product

Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part #'s 900728 900737 900738 900740 909836 110008343 110009769 231201303 Lot #'s 669220 625160 625180 679060 529190 585920 742460 751280 751290 751330 751400 751410 751420 751430 630570

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 #146050. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.