Recalls / —

—#162202

Product

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

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K093474, K111663

Affected lot / code info

Package Lot: 989430; Lot Etched on Product: P0284

Why it was recalled

The drill guides were manufactured with the incorrect color anodization.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

DISTRIBUTORS: Review this notification and ensure that affected team members are aware of the contents. 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Return Authorization Number 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

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

Timeline

Recall initiated

2017-10-25

Terminated

2020-05-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.