Recall Z-1827-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2016-04-01, terminated 2017-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.. Reason: 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-01
- Terminated
- 2017-05-23
- Firm location
- Warsaw, IN, United States
Product description
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.