FDAFDA · Food and drugs·Recall number Z-1826-2016
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
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 904756 Lot #'s 625590
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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