Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- restor3d Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Product Codes/Lot Numbers:
Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1027-2022
Related Recalls
Class I - Dangerous
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.