Smith & Nephew Recalls Oversized Biosure Ratchet Driver for Orthopedic Screws
Smith & Nephew is recalling nine Biosure Ratchet Drivers because they are oversized and may not fit screws properly or may 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 deaths. The hazard is a functional defect (oversized driver) that could lead to procedural issues, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling nine units of the Biosure Ratchet Driver, Product No. 72201888. This arthroscopic surgical instrument is used for the delivery and placement of orthopedic screws. The recall involves lot numbers 50410950 and 50407175.
The recall was initiated because the driver does not meet specifications and is 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 units were distributed worldwide, including in the United States and various international locations. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 9
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 Numbers: 50410950 and 50407175
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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