Class 2 Device Recall Restor3d Disposable Trial, Cervical Cage

• Date Initiated by Firm: March 30, 2022
• Date Posted: April 29, 2022
• Recall Status: Open, Classified
• 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: 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.