Home / Recalls / restor3d Inc. / Z-1028-2022

Z-1028-2022 Class II Terminated

Recalled by restor3d Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
May 11, 2022
Initiation Date
March 30, 2022
Termination Date
August 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

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.

Distribution Pattern

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Code Information

Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Other recalls by restor3d Inc.

  • Z-1026-2022 Class II — Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Ce (March 30, 2022)
  • Z-1027-2022 Class II — Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). (March 30, 2022)