In2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
In2bones USA, LLC is recalling 29 bone screws labeled as fully threaded but actually partially threaded due to a labeling error.
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 due to a labeling error regarding the threading of the bone screws. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
In2bones USA, LLC is recalling 29 units of REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm. The recall is due to a labeling error where the bone screws are specified as fully threaded but are actually partially threaded.
The affected products were distributed nationwide in Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, and Virginia. The products are identified by UDI 00817906023992 and Lot numbers GM008380 and GM007868.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
- Manufacturer
- In2bones USA, LLC
- Hazard
- Affected units
- 29
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 (2)
- UDI: 00817906023992/Lot: GM008380
- GM007868
Distribution
Related recalls
Same manufacturer · In2bones USA, LLC
See all →- ModerateNeoSpan compression staple kits missing Magnetic Resonance Conditional labeling symbol
FDA (Devices) · 2026-06-17
- HighCoLink Bone Graft Harvester Recalled for Breaking at Weld Site
FDA (Devices) · 2021-09-29
- ModerateIn2bones Recalls NeoSpan Compression Staple Kits Due to Incorrect Drill Bit Size
FDA (Devices) · 2019-01-02
- ModerateIn2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
FDA (Devices) · 2018-08-29
- ModerateIn2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
FDA (Devices) · 2018-08-29
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
Similar recalls
- HighOrthopedic Bone Screws Recalled Due to Potential Length Mislabeling
FDA (Devices) · 2021-10-27
- ModerateSynthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling
FDA (Devices) · 2013-12-04
- HighBone Screw Labeling Error: Actual Length May Not Match Package Label
FDA (Devices) · 2021-10-27
- ModerateSmith & Nephew cannulated screw label incorrectly indicates threading type
FDA (Devices) · 2021-10-27
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- HighMedical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
FDA (Devices) · 2024-03-27