Atlas Spine Torque Limiting Handle 6N-m recall
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Why was Atlas Spine Torque Limiting Handle 6N-m recalled?
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots #: 8887, 000073, 000135, 00434, and 02518.
- Product
- Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Recalling firm
- Atlas Spine, Inc.
- Quantity
- 16
- Distribution
- Nationwide Distribution to FL, MO, and WV.
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)