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.
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 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
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