Device product
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Z-1220-2017
Product summary
- Event
- Event 76375
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-1220-2017
Official wording
Reason: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
Code information: 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw
Distribution pattern: Domestic: None VA/DOD: None Foreign: Japan
Derived failure modes
-
Unknown
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.