Device product
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Z-1393-2016
Product summary
- Event
- Event 73659
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1393-2016
Official wording
Reason: Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
Code information: 26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205
Distribution pattern: Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
Derived failure modes
-
Unknown
Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.