Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Reported: June 1, 2016 Initiated: April 1, 2016 #Z-1819-2016
Product Description
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- N/A
- Distribution
- Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.. Recalled by Biomet, Inc.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1819-2016.
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