Device product
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Z-0397-2016
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 72711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0397-2016
Official wording
Reason: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Code information: 1509058
Distribution pattern: US Distribution to the state of :TN
Derived failure modes
-
Unknown
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.