Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect
Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.
What this means for you
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 is classified as FDA Class II and involves a risk of harm (soft tissue irritation and potential need for revision surgery) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling A.L.P.S. 4.0mm Cancellous Locking Screws intended for the stabilization and fixation of fractures, revision procedures, fusions, reconstructions, and non-unions. The recall involves 182,965 units distributed across 49 U.S. states, the District of Columbia, Puerto Rico, and several international countries including Canada, Chile, Costa Rica, and the Netherlands. The affected lots were manufactured between June 1, 2008, and June 1, 2015.
The recall is due to a design defect where the screws feature a single-lead thread instead of the intended triple-lead thread. This defect may cause the screw to sit proud in the plate or fail to lock properly, leading to the screw backing out. If the screw sits proud, it may cause soft tissue irritation. If the screw backs out, a revision surgery may be necessary.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
- Manufacturer
- Biomet, Inc.
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 (20)
- Part number and size (non-sterile) 816140010
- 4.0X10MM
- 816140012
- 4.0X12MM
- 816140014
- 4.0X14MM
- 816140016
- 4.0X16MM
- 816140018
- 4.0X18MM
- 816140020
- 4.0X20MM
- 816140022
- 4.0X22MM
- 816140024
- 4.0X24MM
- 816140026
- 4.0X26MM
- 816140028
- 4.0X28MM
Distribution
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