Biomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect
Biomet, Inc. is recalling 50 A.L.P.S. 3.5mm x 60 mm Cortical Locking Screws because the sterile packaging was not sealed, posing a risk of infection.
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. The hazard is a risk of infection from an unsterile implant, which is a significant health risk, but the source text does not report any actual illnesses, injuries, or hospitalizations, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 50 units of the A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw, a bone fixation screw. The recall is due to a defect where the sterile packaging was not sealed. The specific part number for the affected units is 856135060, and the lot number is 061300.
The distribution of these units was limited to international markets, specifically the Netherlands and Japan. There were no domestic distributions in the United States. The primary hazard associated with this recall is that the implantation of an unsterile screw may lead to infection.
Healthcare providers and patients who have used or possess these specific units should contact Biomet, Inc. for further instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
- Manufacturer
- Biomet, Inc.
- Affected units
- 50
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 (1)
- Part number:856135060 Lot: 061300
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · infection
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19