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.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 174 A.L.P.S. Clavicle Plating Systems used for fixing clavicle fractures and related bone conditions. The recalled systems, distributed nationwide, may experience cold welding of instruments when a drill is inserted through the Soft Tissue Guide, which can prevent the instruments from separating and potentially cause the drill to fracture.
The affected systems are Item Number 233500004 from Lot Numbers 516349 and 545167. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide distribution. Quantity: 174 systems Lot/code info: Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.