restor3d Inc. Recall 89983
Description: Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
restor3d Inc. Recall 89983 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1027-2022 |
| Event ID | 89983 |
| Event Description | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL. |
| Quantity | 4 units |
| Recall Reason | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. |
| Device Classification | 20220511 |
| Device Code Info | Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574 |
| Center Classification Date | 20220429 |
| Recall Initiation Date | 20220330 |
| Recalling Firm | restor3d Inc. |
| Initial Notification | |
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