Zimmer Biomet—ALPS Clavicle Plating System Soft Tissue Guides: Instruments May Become Cold Welded Together When Drill Is Inserted through the Guide
January 6, 2021 | Strategic Insights for Health System
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In a December 30, 2020, Urgent Medical Device Recall letter submitted by an ECRI member hospital, Zimmer Biomet states that instruments may become cold welded together when the drill is inserted through the above soft tissue guides, preventing disassociation of the instruments and potentially leading to an increased risk of drill fracture. Removal of the ALPS clavicle plating system soft tissue guide will leave this set without a drill guide instrument to facilitate use of the 3.5 mm and 2.7 mm non-locking screws in the oblong compression slots or to facilitate implantation of the 3.5 mm and 2.7 mm multi-directional locking screws in a non-fixed angle. Surgeons will be able to implant all locking and non-locking screws in the system at a fixed angle in the locking holes using the F.A.S.T. Grip instruments. Zimmer Biomet also states that this problem may lead to a clinically...