Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Recall Insight

This FDA Devices action (record #Z-1616-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on July 26, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Atlas Spine, Inc. is listed as the recalling firm, operating out of Jupiter, FL. Federal records indicate 16 units are affected.

The documented reason for this recall is: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. Distribution data in the federal record shows the product reached: Nationwide Distribution to FL, MO, and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.