FDAFDA · Food and drugs·Recall number Z-1816-2016
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Published June 1, 2016 · Recall initiated: April 1, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
- Lot
- Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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