Z-0397-2016 Class II Terminated
FDA device recall Z-0397-2016 was initiated by In2Bones, SAS on November 18, 2015 and is designated Class II. Reason for recall: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. The recall status is terminated (terminated August 19, 2016). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2015
- Initiation Date
- November 18, 2015
- Termination Date
- August 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Reason for Recall
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Distribution Pattern
US Distribution to the state of :TN
Code Information
1509058