restor3d Disposable Instrument, Wedge Trial recallZ-1028-2022 · restor3d Inc. · initiated Mar 30, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from restor3d Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1028-2022
- Status
- Terminated
- Initiated by the company
- Mar 30, 2022
- Posted by the FDA
- Apr 29, 2022
- Recalling firm
- restor3d Inc.
- Quantity
- 9 units
- Product code
- LXH
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Product description
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Code information (models, lots, serial numbers)
Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- restor3d Disposable Instrument, Wedge Trial 6101-22200818Restor3d, Inc. · Orthopedic Manual Surgical Instrument1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89983).
- Z-1026-2022 · TerminatedNon-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
- Z-1027-2022 · TerminatedEvans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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