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U.S. Department of Health and Human Services

Class 2 Device Recall Restor3d Disposable Trial, Evans Wedge

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  Class 2 Device Recall Restor3d Disposable Trial, Evans Wedge see related information
Date Initiated by Firm March 30, 2022
Date Posted April 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-1027-2022
Recall Event ID 89983
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Code Information Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
Recalling Firm/
Manufacturer
restor3d Inc.
311 W Corporation St
Durham NC 27701-2409
Manufacturer Reason
for Recall
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
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 4 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.
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