Biomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error
Biomet is recalling 52 locking cortical screws because a 3.5mmx28mm screw was incorrectly labeled as a 3.5mmx38mm screw.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where a shorter screw is mislabeled as a longer one. This fits the rubric for moderate severity, representing a labeling error without reported injuries or fatalities.
Plain-English summary
Biomet, Inc. is recalling 52 units of the 3.5mmx38mm Locking Cortical Screw (Catalog Number 816135038, Lot Number RM244D). The recall was initiated after an investigation identified that a 3.5mmx28mm Cortical Locking Screw was incorrectly labeled as a 3.5mmx38mm Cortical Locking Screw.
The affected devices were distributed in the United States, including the states of Arizona, California, Georgia, Illinois, Kentucky, Michigan, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, and Virginia.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 52
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)
- Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Distribution
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 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 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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
Similar recalls
- HighBiomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect
FDA (Devices) · 2015-07-22
- ModerateZimmer Biomet Recalls Mislabeled Cannulated Screws Due to Labeling Error
FDA (Devices) · 2018-03-21
- ModerateBiomet Recalls Low Profile Non-Locking Screws Due to Anodizing Error
FDA (Devices) · 2015-04-22
- ModerateZimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws
FDA (Devices) · 2016-01-20
- ModerateBiomet Recalls G7 Acetabular Screws Due to Incorrect Diameter Labeling
FDA (Devices) · 2014-01-01
- ModerateOrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error
FDA (Devices) · 2015-09-30