FDA-Device2021-01-27Class II
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Biomet, Inc.
Hazard
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Sold states
Nationwide distribution.
Affected count
174 systems
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0882-2021Don't want to check this manually?
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