Smith & Nephew Recalls Mislabeled Mini-Fragment Bone Plating System Devices
Smith & Nephew is recalling two units of bone plates and screws that were incorrectly labeled as one model but contained a different model.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error rather than a structural defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling two units of bone plates and bone screws from the Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD). The recalled devices, specifically the 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD (REF 74442030), were incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE. Conversely, some devices labeled as the STOUT PLATE contained the STRAIGHT PLATE model.
The recall is due to incorrect labeling of the product. The devices are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones. The recall covers two units distributed to Michigan, Georgia, and Ohio. The specific lot number is 16KM10662C.
Healthcare providers and facilities that have received these devices should stop using them and contact Smith & Nephew for instructions on return or replacement. Patients who have had these devices implanted should contact their healthcare provider for guidance.
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 STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mi
- 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 16KM10662C
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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