Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2046-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 4, 2015

Date Posted: July 15, 2015

Recall Number: Z-2046-2015

Event ID: 71511

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.

Status: Terminated

Product Quantity: 75 units

Code Information:

Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated