FDA Medical Device Recalls (openFDA)
Atlas Spine, Inc.: Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Recall number
- Z-1616-2016
- Recalling firm
- Atlas Spine, Inc.
- Product
- Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Status
- Terminated
- Initiated
- 2013-07-26
- Posted
- not on file
- Terminated
- 2019-07-26
- Reason
- The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
- Root cause
- Device Design
- Action
- Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102.
- Quantity
- 16
- Distribution
- Nationwide Distribution to FL, MO, and WV.
- Lot, serial or model codes
- Lots #: 8887, 000073, 000135, 00434, and 02518.
- 510(k) numbers
- ["K063205","K091406"]
- PMA numbers
- not on file
- Product code
- MQP
- Firm FEI
- 3003855635
- Firm city
- Jupiter
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28