Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0372-2016·Announced 2015-12-16

Smith & Nephew Recalls Anatomically Incorrect Volar Distal Radius Plates

Smith & Nephew is recalling 9 units of PERI-LOC Volar Distal Radius Plates that 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. The hazard involves incorrect labeling and packaging of a medical device, which is a significant error but does not involve a high-risk pathogen or reported serious injury, fitting the Moderate severity criteria for labeling errors.

Plain-English summary

Smith & Nephew, Inc. is recalling 9 units of PERI-LOC Volar Distal Radius Plate Standard 3 Hole Short, Left - 62 MM, Sterile R, REF Number 71863110. The recall involves Batch # 14KT47574. These devices are bone fixation plates intended for prescription use only.

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

The affected units were distributed internationally to Germany, Japan, and Russia. Healthcare providers and patients should verify the anatomical orientation of the plates against the packaging and laser markings before use to ensure the correct device is implanted.

The recalled product

Product: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
packaging-error
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 # 14KT47574

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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