Novapproach Spine, LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X Class IIApr 23, 2026Intervertebral body fusion system straight inserter failed t	Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may res	Class IIDevices	Apr 23, 2026
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLClass IIOct 12, 2022The torque limiting adapter may not stay locked inside of th	The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.	Class IIDevices	Oct 12, 2022