3CorRecalls & reported problems across all models

We found 2 models of 3Cor by Tedan Surgical Innovations, L.L.C. 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

3Cor 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. May 15, 2020Terminated

   Lack of pouch seal. Product is labelled as sterile.

   Z-2525-2020 · Root cause: Packaging change control · Recall details · FDA record ↗

2. May 15, 2020Terminated

   Lack of pouch seal. Product is labelled as sterile.

   Z-2524-2020 · Root cause: Packaging change control · Recall details · FDA record ↗

3Cor models

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

• 3Cor D-0012

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• 3Cor D-0014

  Orthopedic Manual Surgical Instrument
  1 recall0 reports

Other Tedan Surgical Innovations, L.L.C. products

• TSI9 models · 12 reports · 5 recalls