OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Novapproach Spine LLC
- Reason for Recall:
- The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Product Codes/Lot Numbers:
Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0246-2023