Z-2046-2015Class II

A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation...

Name: Z-2046-2015 A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation...
Creator: Biomet, Inc.
Published: 2015-06-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-06-04 / Terminated

FDA source

Biomet, Inc. began a recall of A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures... on 2015-06-04. FDA classified it as Class II and gives the reason as "The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2046-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-07-08
Terminated: 2015-12-22
Recalling firm: Zimmer GmbH
Product: A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
FDA root cause: Process change control
Action: On June 4, 2015 an URGENT MEDICAL DEVICE REMOVAL letter was sent to all consignees. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation; Carefully follow the instructions on the enclosed "Response Form"; Email a copy of the Response Form to [email protected] prior to return of product; Use priority carrier for your shipment; and If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 75 units
Distribution: Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.
Product codes and lots: Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08

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)