Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrum
FDA device recall Z-1028-2022 · posted 2022-04-29 · Terminated
Recall details
- Recalling firm
- restor3d Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 9 units
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Date initiated
- 2022-03-30
- Date posted
- 2022-04-29
- Date terminated
- 2023-08-28
- Location
- Durham, NC
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