Device product
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Z-1306-2018
Product summary
- Event
- Event 79393
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22
- Official record key
device-enforcement:Z-1306-2018
Official wording
Reason: The drill guides were manufactured with the incorrect color anodization.
Code information: Package Lot: 989430; Lot Etched on Product: P0284
Distribution pattern: Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Derived failure modes
-
Unknown
The drill guides were manufactured with the incorrect color anodization.