FDA Enforcement
Class II
Terminated
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.
Recall: Z-0882-2021
·
Reported January 27, 2021
Enforcement
- Recall Number
- Z-0882-2021
- Event ID
- 87095
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 27, 2021
- Initiation Date
- December 23, 2020
- Classification Date
- January 21, 2021
- Termination Date
- April 13, 2023
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
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
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 Info
Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Distribution
Nationwide distribution.
Quantity
174 systems