Date Initiated by Firm | March 30, 2022 |
Date Posted | April 29, 2022 |
Recall Status1 |
Terminated 3 on August 28, 2023 |
Recall Number | Z-1028-2022 |
Recall Event ID |
89983 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument |
Code Information |
Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598
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Recalling Firm/ Manufacturer |
restor3d Inc. 311 W Corporation St Durham NC 27701-2409
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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 | 9 units |
Distribution | US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL. |
Total Product Life Cycle | TPLC Device Report |
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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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