OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneL
Summary
The FDA issued a Class II for OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-000 by Novapproach Spine LLC. Reason: The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged..
Details
Source
Device Recall
External ID
Z-0246-2023
Action Date
2022-11-23
Status
Terminated
Category
device
Product 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.
Lot/Code Info: Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Quantity Affected: 6 devices
Reason for Recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Distribution
US Nationwide distribution in the states of CA and NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-12
Company
Alachua, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Novapproach Spine LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novapproach Spine LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novapproach Spine LLC have FDA actions?
Novapproach Spine LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0246-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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