Recall Z-0882-2021
Biomet, Inc. · initiated December 23, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
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.
FDA-determined cause: Device Design
Action taken
On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier.
Details
- Recall number
- Z-0882-2021
- Initiated
- December 23, 2020
- Posted by FDA
- January 21, 2021
- Terminated
- April 13, 2023
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 174 systems
- Distribution
- Nationwide distribution.
- Recalling firm
- Biomet, Inc., Warsaw, IN