Device product
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.
Z-0882-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 87095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 174 systems
- Official record key
device-enforcement:Z-0882-2021
Official wording
Reason: 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.
Code information: Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Distribution pattern: Nationwide distribution.
Derived failure modes
-
Unknown
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.