Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0143-2022·Announced 2021-10-27

Smith & Nephew cannulated screw label incorrectly indicates threading type

Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.

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: FDA Class II medical device recall involving a labeling error with no reported illnesses or injuries. The mislabeled threading specification is a minor product-label discrepancy without documented patient harm.

Plain-English summary

Smith & Nephew, Inc. is recalling model 71106365S cannulated screws, 6.5mm x 165mm in size (lot 20GT39417), because the product label incorrectly states that the screws are fully threaded when the screws contained in the package are actually partially threaded.

The labeling discrepancy means the product does not match its label description. Surgeons and healthcare providers who rely on the label to determine screw specifications may receive a product with different threading characteristics than expected, which could affect proper surgical placement and implantation.

The affected screws were distributed worldwide, with US distribution in Oklahoma and Tennessee, and also in Canada. Healthcare facilities and medical professionals in these areas who have received this product should verify the actual threading specifications before use.

Patients, healthcare providers, or facilities with this product should contact Smith & Nephew, Inc. for instructions on replacement or return of the affected cannulated screws.

The recalled product

Product: 6.5MMX165MM CANNULATED SCREW
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
threading-mismatch
Affected units: 5

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 (2)

Model 71106365S
Lot 20GT39417

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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