Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Reported: May 11, 2022 Initiated: March 30, 2022 #Z-1027-2022
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.
Details
- Recalling Firm
- restor3d Inc.
- Units Affected
- 4 units
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument. Recalled by restor3d Inc.. Units affected: 4 units.
Why was this product recalled? ▼
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1027-2022.
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