PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 11, 2018 Initiated: October 25, 2017 #Z-1306-2018

Product Description

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
22
Distribution
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403. Recalled by Zimmer Biomet, Inc.. Units affected: 22.
Why was this product recalled?
The drill guides were manufactured with the incorrect color anodization.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1306-2018.