Device product
Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
Z-2245-2018
Product summary
- Event
- Event 79754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-2245-2018
Official wording
Reason: Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Code information: FL00860
Distribution pattern: Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
Derived failure modes
-
Unknown
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.