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.
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: 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Smith & Nephew, Inc., Endoscopy Div.
See all →- HighSmith & Nephew Recalls High Flow Irrigation Extender for Separation Risk
FDA (Devices) · 2016-02-24
- ModerateSmith & Nephew Recalls Oversized Biosure Orthopedic Screw Drivers
FDA (Devices) · 2016-02-10
- HighSmith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach
FDA (Devices) · 2015-10-28
- HighSmith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach
FDA (Devices) · 2015-10-28
- HighSmith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach
FDA (Devices) · 2015-10-28
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07