FDAClass IIApril 11, 2018

A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. recall

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

Why was A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. recalled?

The drill guides were manufactured with the incorrect color anodization.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Package Lot: 989430; Lot Etched on Product: P0284

Product
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Recalling firm
Zimmer Biomet, Inc.
Quantity
22
Distribution
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls