Z-1306-2018Class II

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

Name: Z-1306-2018 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI...
Creator: Zimmer Biomet, Inc.
Published: 2017-10-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-25 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 on 2017-10-25. FDA classified it as Class II and gives the reason as "The drill guides were manufactured with the incorrect color anodization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1306-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Posted: 2018-04-03
Terminated: 2020-05-01
Recalling firm: Zimmer GmbH
Product: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Product code: HRS Plate, Fixation, Bone
Reason for recall: The drill guides were manufactured with the incorrect color anodization.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by 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].
Quantity in commerce: 22
Distribution: Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Product codes and lots: Package Lot: 989430; Lot Etched on Product: P0284

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1306-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1306-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)