Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1854-2017·Announced 2017-04-26

Smith & Nephew Recalls Peri-Loc VLP Self-Tapping Cortex Screws Due to Labeling Error

Smith & Nephew is recalling specific Peri-Loc VLP self-tapping cortex screws because the expiration dates printed on the labels are incorrect and later than the actual dates.

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, but the source text identifies the issue as a labeling error regarding expiration dates without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Smith & Nephew, Inc. is recalling the Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, REF 71801306. The recall is limited to Batch 15HM05197. The product is a sterile orthopedic screw intended for medical use.

The reason for the recall is that the expiration dates on the product labeling are incorrect. The actual expiration dates for these units are earlier than the dates printed on the labels. This labeling error could lead to the use of expired medical devices.

The affected units were distributed worldwide, including nationwide in the United States and internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore. Healthcare providers and facilities that have received this specific batch should stop using the product and contact Smith & Nephew for instructions on return or disposal.

The recalled product

Product: Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
expired-product
Affected units: 1

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 15HM05197

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Smith & Nephew, Inc.

See all →

High
TRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
Moderate
Bone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
Moderate
Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
High
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
High
Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13

Same hazard · mis labeling