Recall Z-2046-2015 — 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.
U.S. FDA — Device Enforcement · United States · 2015-06-04 · Class II
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Reported risk: 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.
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