Smith & Nephew Recalls Trigen Bone Screws Due to Incorrect Coating
Smith & Nephew is recalling 23 units of 4.5 mm Trigen bone screws that were incorrectly anodized with a gold coating instead of gray.
What this means for you
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 the hazard is a labeling error (incorrect anodizing color) without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Smith & Nephew Inc. is recalling 23 units of TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, REF 71645437. The recall involves Lot Number 12FM12182. These orthopedic surgery devices were distributed nationwide, including in California, Florida, Georgia, Massachusetts, Michigan, North Carolina, South Carolina, Ohio, and Missouri.
The recall was initiated because the 4.5 mm diameter screws were incorrectly anodized with a gold coating, which indicates a 5 mm diameter, instead of the correct gray coating for 4.5 mm diameter screws. This labeling error could lead to the use of the wrong size screw during orthopedic procedures.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
- Manufacturer
- Smith & Nephew Inc
- Hazard
- Affected units
- 23
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)
- Lot Number 12FM12182
Distribution
Related recalls
Same manufacturer · Smith & Nephew Inc
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
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