Biomet Recalls A.L.P.S. Clavicle Plating System Due to Drill Fracture Risk
Biomet is recalling 174 A.L.P.S. Clavicle Plating Systems because instruments may cold weld, preventing disassociation and increasing the chance of drill fracture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm (drill fracture) during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 174 units of the A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004. The product is indicated for the fixation of fractures, osteotomies, and non-unions of the clavicle, including osteopenic bone. The recall covers lots 516349 and 545167, which were distributed nationwide.
The recall was initiated because the instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This condition prevents the disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Healthcare providers and facilities should check their inventory for the specific item number and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to Biomet, Inc. in accordance with the company's instructions.
The recalled product
- 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.
- Manufacturer
- Biomet, Inc.
- Affected units
- 174
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Item: 233500004
- Lot: 516349
- 545167
- UDI: (01)0088030483464(10)516349
- (01)00880304834644(11)190208(10)545167
Distribution
Distributed nationwide across the United States.
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