Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.

FDA device recall Z-1828-2016 · posted 2016-05-26 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

MBI

Distribution

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

Date initiated

2016-04-01

Date posted

2016-05-26

Date terminated

2017-05-23

Location

Warsaw, IN

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