Recall Z-1028-2022
restor3d Inc. · initiated March 30, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Codes / lots: Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598
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: Process change control
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.
Details
- Recall number
- Z-1028-2022
- Initiated
- March 30, 2022
- Posted by FDA
- April 29, 2022
- Terminated
- August 28, 2023
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Recalling firm
- restor3d Inc., Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1026-2022 Class II | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical…Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | 03/30/2022Terminated |
| Z-1027-2022 Class II | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018).…During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts… | 03/30/2022Terminated |