PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 15, 2015 Initiated: June 4, 2015 #Z-2046-2015

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.

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Biomet, Inc.. Units affected: 75 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 15, 2015. Severity: Moderate. Recall number: Z-2046-2015.