Recall Z-1028-2022 ยท LXH Orthopedic Manual Surgical Instrument
restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
| Date | Apr 29, 2022 (initiated Mar 30, 2022) |
| Status | Terminated |
| Reason | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. |
| Root 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 | 9 units |
| Distribution | US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.