OneLIF Interbody Cage Inserter Attachment Failure Recall
Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses. The hazard is functional failure that may cause procedural delay or alternative selection, but no direct patient harm has been documented in the source text.
Plain-English summary
Novapproach Spine, LLC is recalling certain OneLIF Interbody Cage models distributed nationwide in NY, CT, CA, TX, FL, and MI. The straight inserter designed for these cages may fail to properly attach, which could prevent secure engagement of the implant with the inserter during spinal fusion procedures.
This attachment failure could result in procedural delays and may require surgeons to select an alternative implant. A total of 1,259 affected cages have been identified across multiple cage sizes and implant kit variants. The specific lot numbers for affected units are documented in the FDA recall notice.
Patients or healthcare providers who have received or are aware of this product should contact Novapproach Spine, LLC. Physicians should review affected lot numbers and consider the attachment issue when planning or performing intervertebral body fusion procedures with these cages.
The recalled product
- Product
- OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm…
- Manufacturer
- Novapproach Spine, LLC
- Category
- Medical Device — Spinal Implant
- Affected units
- 1,259
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/ Cage Lots: 010-107-1007/G07001010710070/ 103003
- 105701
- 118001
- 129301
- 010-107-1007-2/G070010107100720/ 114301
- 117509
- 128703
- 010-107-1209/G07001010712090/ 102714
- 105702
- 117501
- 010-107-1411/G07001010714110/ 103019
- 105703
- 010-107-1613/G07001010716130/ 103020
- 105704
- 127701
- 010-113-1006/G07001011310060/ 103021
- 105705
- 118002
- 129801
- 010-113-1006-2/G070010113100620/ 117510
Distribution
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