PRESSFT, HI-FI NP261Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854036638), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K112965); 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 18, 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.

• MalfunctionJun 21, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, NP261, PRESSFT 2.6 WAS BEING USED ON (B)(6) 2022 DURING AN INSTABILITY REPAIR PROCEDURE WHEN IT WAS REPORTED THAT ¿CASE WAS ASSISTED BY DISTRIBUTOR STAFF ON PLACEMENT OF PEEK ANCHOR ON 3' O CLOCK POSITION. POST DRILLING IT WAS DIRECTLY PUNCHED IN TILL THE LASER LINE AND DRIVER REMOVED AND KNOT WAS TRIED THAT TIME IT WAS SEEN THE PEEK ANCHOR IS SPLIT. ANOTHER ALL SUTURE YKNOT FLEX ANCHOR WAS PLACED ON 5'30 POSITION POST ANCHOR FIXATION ON KNOT TYING THE ANCHOR BAILED OUT." FOLLOW UP ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND "IT WAS RETRIEVED USING A GRASPER". THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION TO PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753357 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112965. One submission often covers many models, so check the product and lot details in each record.

• Z-0063-2013 · Jun 26, 2012 · Terminated
  "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthop
• Z-0067-2013 · Jun 26, 2012 · Terminated
  "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthope
• Z-0065-2013 · Jun 26, 2012 · Terminated
  "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orth
• Z-0068-2013 · Jun 26, 2012 · Terminated
  NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
• Z-0064-2013 · Jun 26, 2012 · Terminated
  "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthope
• Z-0066-2013 · Jun 26, 2012 · Terminated
  "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orth