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U.S. Department of Health and Human Services

Class 2 Device Recall OneLIF

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  Class 2 Device Recall OneLIF see related information
Date Initiated by Firm October 12, 2022
Date Posted November 17, 2022
Recall Status1 Completed
Recall Number Z-0246-2023
Recall Event ID 91016
510(K)Number K211769  K211769  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
Product 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.
Code Information Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Recalling Firm/
Manufacturer		 Novapproach Spine LLC
13900 Tech City Cir Ste 300
Alachua FL 32615-6091
For Additional Information Contact Ron Green
352-318-2584
Manufacturer Reason
for Recall		 The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters dated 10/10/2022 via email on 10/12/2022. The email briefly described the product to be recalled, the issue, and what the consignee needed to do. The letter, which was also mailed to the consignee via certified mail, return receipt, on 10/12/2022, describes the product, reason for recall, and provides the actions necessary to complete the product removal. The actions include immediately discontinuing use of the torque adapter, remove it from the consigned OneLIF INS-Instrument Kits(s), receive a replacement OneLIF Torque adapter Lot 106607 to add back to the kit, and receive a return label to return the torque adapter to the location provided. No response form was enclosed. The recalling firm will be coordinating with a third-party logistics provider to track the return of the product for quarantine and storage until all product has been returned.
Quantity in Commerce 6 devices
Distribution US Nationwide distribution in the states of CA and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OVD and Original Applicant = NovApproach Spine
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