NanoTack CAT01386Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252633006), received between Apr 6, 2021 and Mar 21, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K131769); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583327 ↗
• MalfunctionMar 21, 2023Expiration Date Error; Activation, Positioning or Separation Problem; Expiration Date Error; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583324 ↗
• InjuryOct 18, 2022Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620991 ↗
• MalfunctionApr 6, 2021Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619411 ↗
• MalfunctionApr 6, 2021Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131769. One submission often covers many models, so check the product and lot details in each record.

• Z-2645-2023 · Aug 23, 2023 · Open, Classified
  Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
• Z-1634-2016 · Apr 12, 2016 · Terminated
  CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT0246