Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
FDA Recall Z-1819-2016 · Posted 2016-05-26
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2016-04-01
Date Terminated2017-05-23
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.
Firm Action
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
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.