FDAFDA · Food and drugs·Recall number Z-1827-2016
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
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 900728 900737 900738 900740 909836 110008343 110009769 231201303 Lot #'s 669220 625160 625180 679060 529190 585920 742460 751280 751290 751330 751400 751410 751420 751430 630570
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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