medical MODERATE Updated 2022-05-11

restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickn

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Recalled Product

Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

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Hazard / Issue

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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