Smith & Nephew Recalls Mislabelled Peri-Loc Volar Distal Radius Plates
Smith & Nephew is recalling 12 units of Peri-Loc Volar Distal Radius plates that were laser-etched as left plates but packaged as right plates.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (left vs. right) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 12 units of the Peri-Loc Volar Distal Radius - Right 3H Std Head Locking Plate, 62 mm length, SST plate (Ref 71823114). The specific lot number is 16DM15958. The products were distributed internationally to India.
The recall was initiated because the lot of left plates was laser-etched and packaged as right plates. This mislabeling could lead to the use of the incorrect anatomical side during a surgical procedure.
Healthcare providers and patients who have received these specific units should contact Smith & Nephew, Inc. for further instructions on how to return or replace the affected products.
The recalled product
- Product
- PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 12
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 16DM15958
Distribution
Distribution scope not specified by the agency.
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