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U.S. Department of Health and Human Services

Class 2 Device Recall Restor3d Disposable Trial, Cervical Cage

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  Class 2 Device Recall Restor3d Disposable Trial, Cervical Cage see related information
Date Initiated by Firm March 30, 2022
Date Posted April 29, 2022
Recall Status1 Terminated 3 on August 28, 2023
Recall Number Z-1026-2022
Recall Event ID 89983
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Code Information Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Recalling Firm/
Manufacturer		 restor3d Inc.
311 W Corporation St
Durham NC 27701-2409
Manufacturer Reason
for Recall		 Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
FDA Determined
Cause 2		 Process change control
Action An email was sent out to the consignees on 03/31/2022. All customers were instructed to segregate any affected product and contact Restor3d. If all product has already been returned to restor3d, the consignee is to indicate that on the enclosed response form. On 04/19/2022, the firm extended the recall to two additional lots. The recall notification was sent to the consignees via email with a request for all affected product to be returned.
Quantity in Commerce 14 units
Distribution US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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