Biomet, Inc. Recall 87095
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.
Biomet, Inc. Recall 87095 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0882-2021 |
| Event ID | 87095 |
| Event 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. |
| Product Type | Devices |
| Distribution | Nationwide distribution. |
| Quantity | 174 systems |
| Recall 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. |
| Device Classification | 20210127 |
| Device Code Info | Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167 |
| Center Classification Date | 20210121 |
| Recall Initiation Date | 20201223 |
| Recalling Firm | Biomet, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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