Biomet, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Item: 233500004, Lot: 516349, 545167, UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Products Sold
Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167
Biomet, Inc. is recalling A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indi due to The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instrume. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026