Smith & Nephew Recalls Oversized Biosure Orthopedic Screw Drivers
Smith & Nephew is recalling 157 Biosure Drivers that are oversized and may fail to insert screws properly or cause screws to stick.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (oversized driver) that may impede surgical procedure execution, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling 157 units of the Biosure Driver, Product No. 72201887. This orthopedic manual surgical instrument is used for the delivery and placement of orthopedic screws. The recall covers specific lot numbers: 50409038, 50404149, and 50399964.
The recall was initiated because the drivers do not meet specifications and are oversized. This defect may prevent the driver from being fully inserted into the screw, or it may cause the screw to become stuck on the driver.
The affected products were distributed worldwide, including in the United States and various international locations. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 157
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 (3)
- Lot Numbers: 50409038
- 50404149
- 50399964
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc., Endoscopy Div. 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.
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