Recall Z-1306-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1306-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-25

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-10-25, terminated 2020-05-01. It names 2 FDA 510(k) clearances: K111663, K093474. Product: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403. Reason: The drill guides were manufactured with the incorrect color anodization..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Terminated: 2020-05-01
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K111663 — TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.·cleared 2012-03-12
K093474 — DEPUY FRACTURE AND FUSION PLATING SYSTEMDePuy Orthopaedics, Inc.·cleared 2010-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.