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Terminated

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

FDA Recall Z-1306-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2017-10-25
Date Terminated2020-05-01
Product Quantity22

Reason for Recall

The drill guides were manufactured with the incorrect color anodization.

Firm Action

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 [email protected] 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 [email protected] 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 [email protected].

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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