FDA-Device2015-07-15Class II
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.
Biomet, Inc.
Hazard
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.
Sold states
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.
Affected count
75 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2015Don't want to check this manually?
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