FDAFDA · Food and drugs·Recall number Z-1306-2018
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Published April 11, 2018 · Recall initiated: October 25, 2017
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
The drill guides were manufactured with the incorrect color anodization.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
- Lot
- Package Lot: 989430; Lot Etched on Product: P0284
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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