Biosure Driver recall
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Why was Biosure Driver recalled?
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 50409038, 50404149, 50399964
- Product
- Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div.
- Quantity
- 157
- Distribution
- Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
- Recall date
- February 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)