Novapproach Spine recalls OneLIF Torque Limiting Adapter (Catalog #015-010-0000) due to potential failure to stay locked in ratcheting handle. Affected kits include specific model numbers.
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Novapproach Spine is recalling a torque limiting adapter used in spinal surgery kits because it may not stay locked in place after being fully engaged. This could lead to unintended movement during procedures, potentially causing injury.
The torque adapter may not stay securely locked in the ratcheting handle after full engagement. This could allow unintended movement during spinal surgery, potentially causing injury to the patient or surgeon.
Surgical teams using Novapproach Spine's OneLIF Interbody System instrument kits with the specific torque adapter (Catalog #015-010-0000) are most at risk. The recall affects kits with model numbers 504, 505, 506, 501, 101, and 105.
Check if your OneLIF Torque Limiting Adapter has Catalog #015-010-0000. Affected kits include model numbers 504, 505, 506, 501, 101, and 105 from Novapproach Spine.
Verify the catalog number on the adapter; affected units have Catalog #015-010-0000.
Reach out to Novapproach Spine for guidance on next steps if you have the recalled adapter.
The adapter may not stay locked in place after full engagement, which could lead to unintended movement during surgery. This is why it's being recalled.
Kits with model numbers 504, 505, 506, 501, 101, and 105 from Novapproach Spine's OneLIF Interbody System.
Check the catalog number on the adapter. If it's #015-010-0000, contact Novapproach Spine for further instructions.
We’ve drafted a message you can send Novapproach Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-0246-2023 — Novapproach Spine Novapproach Spine Hello, I own a Novapproach Spine that is covered by recall Z-0246-2023 from Novapproach Spine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
