Device product
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Z-0699-2016
Product summary
- Event
- Event 72908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157
- Official record key
device-enforcement:Z-0699-2016
Official wording
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.
Code information: Lot Numbers: 50409038, 50404149, 50399964
Distribution pattern: 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.
Derived failure modes
-
Potency or specification failure
does not meet specification