FDA-Device2018-04-11Class II
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Zimmer Biomet, Inc.
Hazard
The drill guides were manufactured with the incorrect color anodization.
Sold states
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Affected count
22
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2018Don't want to check this manually?
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