NanoTack CAT02969Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327294606), received between Dec 16, 2020 and Jun 19, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K131769, K173074); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT FOR THE INVOLVED NANOTACK TT ANCHOR, WHILE TENSIONING THE ANCHOR USING THE NEW CURVED PIVOT KNOT PUSHER, THE TAPE RIPPED AT THE POINT WHERE IT INTERFACES WITH THE ANCHOR. AFTER THESE FAILURES, THE SURGEON MADE THE DECISION TO ABANDON THE LABRAL REPAIR AND INSTEAD DEBRIDE AND REMOVE THE PATIENT¿S LABRUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565872 ↗
• InjuryOct 8, 2024Material Fragmentation; Material Fragmentation

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

  Patient problems: Insufficient Information

  MAUDE report 20402353 ↗
• MalfunctionFeb 28, 2024Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803789 ↗
• MalfunctionApr 26, 2022Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214817 ↗
• MalfunctionMar 3, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408096 ↗
• MalfunctionDec 16, 2020Break

  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 11016254 ↗
• MalfunctionDec 16, 2020Break

  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 11016229 ↗
• MalfunctionDec 16, 2020Break

  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 11016146 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131769, K173074. 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