restor3d Recalls
3 recalls on record · May 11, 2022 to May 11, 2022 · Medical Devices
May 11, 2022Medical DevicesFDA
restor3d Inc. recalls Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instru
Hazard: During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
May 11, 2022Medical DevicesFDA
restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Hazard: During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
May 11, 2022Medical DevicesFDA
restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials.
Hazard: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.