Smith & Nephew Mini-Fragment Plating System Recalled for Labeling Error
Smith & Nephew is recalling two units of bone plates due to incorrect labeling of the plate type.
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, which typically corresponds to a moderate severity score. The hazard is a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Smith & Nephew, Inc. is recalling two units of the Mini-Fragment Plating System, specifically the 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD (Ref 74442024). The recall is due to a labeling error where the devices were incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE but actually contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE, and vice versa.
The affected devices are sterile bone plates and bone screws intended for the internal fixation of small bones and small bone fragments. The recall involves Lot number 15GM08498C. The products were distributed in the United States to the states of Michigan, Georgia, and Ohio.
Healthcare providers and facilities that have received these specific units should stop using them and contact Smith & Nephew for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fr
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 2
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 15GM08498C
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. 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.
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