Recall Z-0699-2016— Smith & Nephew, Inc., Endoscopy Div.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., Endoscopy Div., initiated 2013-04-04, terminated 2021-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument. Reason: 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..
- Recalling firm
- Smith & Nephew, Inc., Endoscopy Div.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-04
- Terminated
- 2021-03-22
- Firm location
- Mansfield, MA, United States
Product description
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.