Bone Screw Labeling Error: Actual Length May Not Match Package Label
Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.
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: This is a risk-of-harm product (surgical implant with potential dimension mismatch) where no injuries have been reported. Incorrect bone screw length could affect surgical fixation and implant stability. FDA classified the recall as Class II; the absence of reported injuries combined with a theoretical hazard supports a High severity rating.
Plain-English summary
Limacorporate S.p.A is recalling REF 8420.15.010 bone screws (titanium alloy Ti6Al4V, self-tapping, 6.5 mm diameter, 20 mm nominal length) distributed in boxes of 200 units. The recall involves a potential labeling discrepancy where the length printed on the package may not correspond to the actual length of the screws included.
If the actual length of a bone screw differs from the labeled length, surgeons performing orthopedic procedures may inadvertently select or install a screw of incorrect dimensions. A screw that is shorter than labeled may not provide adequate fixation, while a screw that is longer than labeled may protrude and cause tissue damage. Either scenario could compromise implant stability and affect surgical outcomes.
The recalled screws have been distributed worldwide, including in the United States to California, Florida, Missouri, Kansas, Colorado, Texas, Illinois, Pennsylvania, New York, North Carolina, Michigan, Massachusetts, and Oklahoma. International distribution includes Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden. The affected product lot is identified by code 2103825 and UDI (01)08033390018845.
Healthcare providers and patients should contact Limacorporate S.p.A or the FDA for instructions on product verification and corrective action before using any affected screws. Do not implant screws until the length discrepancy has been verified and resolved.
The recalled product
- Product
- REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 200
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)
- 2103825
Distribution
Part of a larger recall action
This product is one of 2 recalled by Limacorporate S.p.A under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Limacorporate S.p.A
See all →- HighPRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall
FDA (Devices) · 2025-07-02
- HighPRIMA 2MM Eccentrical Adaptor With Screw Sterile Medical Device
FDA (Devices) · 2025-07-02
- HighTEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
FDA (Devices) · 2025-01-01
- HighPRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk
FDA (Devices) · 2024-01-24
- HighMedical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
FDA (Devices) · 2023-12-20
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02