Z-1616-2016Class II

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

Name: Z-1616-2016 Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Creator: Atlas Spine, Inc.
Published: 2013-07-26
License: https://open.fda.gov/license/

Atlas Spine, Inc. / initiated 2013-07-26 / Terminated / root cause: design

FDA source

Atlas Spine, Inc. began a recall of Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position on 2013-07-26. FDA classified it as Class II and gives the reason as "The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1616-2016
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Posted: 2016-05-06
Terminated: 2019-07-26
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
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Root cause tag: design
FDA 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 in commerce: 16
Distribution: Nationwide Distribution to FL, MO, and WV.
Product codes and lots: Lots #: 8887, 000073, 000135, 00434, and 02518.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1616-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

Product code MQP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)