Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0373-2016·Announced 2015-12-16

Smith & Nephew Volar Distal Radius Plates Recalled for Incorrect Marking

Smith & Nephew is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATES because they were laser marked and packaged with incorrect anatomical orientation.

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 involves incorrect labeling/packaging of a medical device without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Smith & Nephew, Inc. is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, REF Numbers: 71863114. The devices were distributed internationally to Germany, Japan, and Russia. The specific batch number is 14KT47575.

The recall was initiated because the devices were packaged and laser marked anatomically incorrect. Specifically, Left plates were laser marked and packaged as Right plates, and Right plates were laser marked and packaged as Left plates.

Healthcare providers and patients should stop using these specific units and contact Smith & Nephew for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

Product: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
incorrect-orientation
Affected units: 9

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)

Batch # 14KT47575

Distribution

Distribution scope not specified by the agency.

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.

See all 2 products in this recall →

Same manufacturer · Smith & Nephew, Inc.

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