Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
FDA Recall Z-1616-2016 · Posted None
Recalling FirmAtlas Spine, Inc.
Recall StatusTerminated
Product CodeMQP
Date Initiated2013-07-26
Date Terminated2019-07-26
Product Quantity16
Reason for Recall
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution to FL, MO, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.