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.
What this means for you
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.
- Hazard
- mis-labeling
- threading-mismatch
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.
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