Device product
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Z-1816-2016
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 74038
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1816-2016
Official wording
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.
Code information: Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280
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.
Derived failure modes
-
Sterility assurance
sterile barrier to be compromised