Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.
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: This is an FDA Class II recall with no reported injuries or illnesses. The defect is a manufacturing quality issue (undersized socket) that renders the device non-functional rather than causing harm; affected units would require replacement, which is a procedural inconvenience rather than a safety hazard.
Plain-English summary
Smith & Nephew, Inc. is recalling the META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM (REF: 71642690, Lot: 24CT81426) distributed nationwide. The compression screw in this kit may have an undersized hexagon socket, making the screw non-functional and unable to serve its intended purpose.
Affected units have been distributed nationwide in Florida, New Hampshire, Texas, California, Ohio, New York, Alabama, Iowa, Massachusetts, Nevada, Missouri, Washington, Louisiana, Tennessee, North Carolina, Kentucky, New Mexico, New Jersey, Arizona, and South Africa. The defect requires replacement of the affected screw with an adequately sized screw, and such exchange may take more than 30 minutes.
Healthcare providers and facilities that have received this product should identify any affected units and discontinue use. Contact Smith & Nephew for guidance on replacement screws and exchange procedures.
The recalled product
- Product
- META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 75
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)
- UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Distribution
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