restor3d Disposable Instrument, Wedge TrialRecalls & reported problems across all models

We found 2 models of restor3d Disposable Instrument, Wedge Trial by Restor3d, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

restor3d Disposable Instrument, Wedge Trial recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 30, 2022Terminated

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

   Z-1028-2022 · Root cause: Process change control · Recall details · FDA record ↗

2. Mar 30, 2022Terminated

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

   Z-1027-2022 · Root cause: Process change control · Recall details · FDA record ↗

restor3d Disposable Instrument, Wedge Trial models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• restor3d Disposable Instrument, Wedge Trial 6101-20181018

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• restor3d Disposable Instrument, Wedge Trial 6101-22200818

  Orthopedic Manual Surgical Instrument
  1 recall0 reports

Other Restor3d, Inc. products

• Veritas rTSA7 models · 7 reports · 1 recall