Z-0882-2021 Class II Terminated
FDA device recall Z-0882-2021 was initiated by Biomet, Inc. on December 23, 2020 and is designated Class II. 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 o… The recall status is terminated (terminated April 13, 2023). Affected quantity: 174 systems.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 23, 2020
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174 systems
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.
Distribution Pattern
Nationwide distribution.
Code Information
Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167