Smith & Nephew Recalls D-RAD Self-Tapping Locking Screws
Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.
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 source text does not report any illnesses or injuries. The defect is a minor dimensional tolerance issue (0.002-0.003 inch) without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling one lot of D-RAD Self-Tapping Locking Screws intended for the fixation of fractures involving the distal radius. The recalled product is the D-RAD 2.4MM X 10MM S-T Locking Screw, Reference 74692410, Lot Number 17GM04522. A total of 59 units were distributed to the United States, Puerto Rico, and Malaysia.
The recall was initiated because the screws were machined out of specification. Specifically, the screws measured over tolerance within the head thread form by 0.002 to 0.003 inch. The source text does not report any illnesses, injuries, or adverse events associated with the use of these devices.
Healthcare providers and facilities that have received these specific screws should stop using them and contact Smith & Nephew, Inc. for instructions on return or disposal. Consumers should not use these medical devices and should consult their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 59
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)
- Lot Number 17GM04522
Distribution
Distributed in 1 state:
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