Z-1027-2022 Class II Terminated
FDA device recall Z-1027-2022 was initiated by restor3d Inc. on March 30, 2022 and is designated Class II. 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. The recall status is terminated (terminated August 28, 2023). Affected quantity: 4 units.
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
- 4 units
Product Description
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). 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: 6101-20181018; Lot: 2022010031; UDI: 00840097501574