FDA recall Z-1306-2018

Zimmer Biomet, Inc. · Class II · device

Product

A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403

Reason for recall

The drill guides were manufactured with the incorrect color anodization.

Distribution

Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.

Key facts

Status
Terminated
Initiation date
2017-10-25
Report date
2018-04-11
Termination date
2020-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2018