TWINFIX 7210292Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010533821), received between Dec 29, 2020 and Dec 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K972326); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN THE ANCHOR WAS BEING INTRODUCED, THERE WAS RESISTANCE IN THE BONE AND THE ANCHOR LOOSE HANDLE AND CANNOT BE FURTHER INTRODUCED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE IMPACTING IT ON THE SAME BONE HOLE. THERE WAS NO DELAY OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091530 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972326. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.