Z-1616-2016 Class II Terminated
FDA device recall Z-1616-2016 was initiated by Atlas Spine, Inc. on July 26, 2013 and is designated Class II. Reason for recall: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. The recall status is terminated (terminated July 26, 2019). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2016
- Initiation Date
- July 26, 2013
- Termination Date
- July 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Reason for Recall
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Distribution Pattern
Nationwide Distribution to FL, MO, and WV.
Code Information
Lots #: 8887, 000073, 000135, 00434, and 02518.