TSI DS-0012Recalls & reported problems
Tedan Surgical Innovations, L.L.C. · DISTRACTION SCREW, 12 MM, STERILE, 5/BOX · Class 1
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2526-2020 · Root cause: Packaging change control · FDA record ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.