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.
Reported: January 27, 2021 Initiated: December 23, 2020 #Z-0882-2021
Product Description
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.
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 174 systems
- Distribution
- Nationwide distribution.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 174 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2021. Severity: Moderate. Recall number: Z-0882-2021.
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