ZipFix 03.501.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 10887587010847), received between May 20, 2014 and Feb 5, 2026 — classified as 8 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (121 reports).

3 other recalls cover devices cleared under the same FDA submission (K110789); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Mechanical Problem

  IT WAS REPORTED THAT INSTRUMENT TIP DOES NOT ENGAGE THE ZIP TIES OR RATCHET TO TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270418 ↗
• MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT A TRIGGER OF THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS NOT WORKING CORRECTLY AND BECAME STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192163 ↗
• MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE APPLICATION INSTRUMENTS; TRIGGER NOT WORKING CORRECTLY; GETS STUCK. THE EVENT OCCURRED IN PRE-SURGERY AND THERE WERE NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191407 ↗
• MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam

  IT WAS REPORTED ON AN UNKNOWN DATE APPLICATION INSTRUMENTS; TRIGGER NOT WORKING CORRECTLY; GETS STUCK. THE EVENT OCCURRED IN PRE-SURGERY AND THERE WERE NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191406 ↗
• MalfunctionJan 8, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY IT WAS OBSERVED THAT THE CUTTING ARM OF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX DIDN'T STAY UP AND DIDN'T ALLOW FOR TENSIONING TO WORK. THERE WAS NO PATIENT HARM. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005875 ↗
• MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICES ARE NOT PULLING CORRECTLY; STIFF. THE LEVER THAT CUTS IS VERY WOBBLY. THE ISSUE WAS OBSERVED DURING PRE-SURGERY AND NO INJURIES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905011 ↗
• MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICES ARE NOT PULLING CORRECTLY; STIFF. THE LEVER THAT CUTS IS VERY WOBBLY. THE ISSUE WAS OBSERVED DURING PRE-SURGERY AND NO INJURIES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905004 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX CUTTING LEVER BROKE OFF THE APPLICATOR GUN. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919740 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ITEM WAS NOT TIGHTENING. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED.

  Patient problems: Insufficient Information

  MAUDE report 21919728 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX WAS NOT TIGHTENING. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED.

  Patient problems: Insufficient Information

  MAUDE report 21919696 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX NOT TIGHTENING. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919665 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WOULD NOT TENSION.

  Patient problems: Insufficient Information

  MAUDE report 21604105 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE DURING TESTING AFTER THE PRODUCT CAME THROUGH THE WASH, IT WAS DISCOVERED THAT THE ZIPFIX GUN BECAME STUCK IN THE TOP POSITION AND WOULD NOT RELEASE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274052 ↗
• MalfunctionMar 28, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX DEVICE CUTS BUT WILL NOT LOCK DOWN THE ZIP TIE. THE ISSUE WAS OBSERVED DURING SURGERY. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR SNAL ZIPFIX THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18991571 ↗
• MalfunctionMar 28, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX DEVICE CUTS BUT WILL NOT LOCK DOWN THE ZIP TIE. THE ISSUE WAS OBSERVED DURING SURGERY. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. THIS REPORT IS FOR ONE (1) APPLIC-INSTR F/STERNAL ZIPFIX THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18991374 ↗
• MalfunctionMar 27, 2024Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED THAT ON 12-MARCH-2024 THE ZIPFIX APPLICATOR IN QUESTION WAS NOT WORKING. THE DEVICE WAS NOT RATCHETING AND WAS NOT CUTTING SUFFICIENTLY. THERE WERE NO ISSUES REPORTED DURING A PROCEDURE, THE EVENT WAS OBSERVED WHILE TESTING ON THE BACK TABLE IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY, A DIFFERENT PRODUCT WAS USED TO CONTINUE WITH THE OPERATION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986047 ↗
• MalfunctionMar 15, 2024Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 WHEN USING THE ZIPFIX SYSTEM TENSION CLAMP, IT WOULDN¿T WORK. THE SURGEON WAS REQUIRED TO PLACE THE SYSTEM MANUALLY USING FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 15 MINUTES. THIS REPORT IS FOR AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914561 ↗
• MalfunctionFeb 26, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON FEBRUARY 9, 2024, THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX TABS ON THE SIDE TO HOLD THE CUTTING TOOL WAS BROKEN AND WOULD NOT HOLD TENSION. THE ISSUE WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR SNAL ZIPFIX THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776640 ↗
• MalfunctionFeb 6, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON JANUARY 22, 2024, THE ITEM TENSION WAS NOT TIGHTENING PROPERLY. THE ISSUE WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. THIS REPORT INVOLVES ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651237 ↗
• MalfunctionJan 25, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 1, 2024, THE DISTAL PART OF THE ZIPFIX APPLICATION INSTRUMENT, THAT CUTS, BROKE. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER APPLICATOR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18583103 ↗
• MalfunctionNov 1, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE APPLICATION INSTRUMENT FOR SNAL ZIPFIX IS NOT CRIMPING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THIS REPORT INVOLVES ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX.. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049842 ↗
• MalfunctionOct 5, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ZIPFIX APPLICATOR DID NOT WORK PROPERLY. THE TRIGGER GOT STUCK, AND THE ZIPFIX CABLE WOULD NOT ADVANCE UP THE APPLICATOR TO TENSION THE CABLE EFFECTIVELY. THE SURGEON HAND TIGHTENED THE ZIPFIX CABLE. THE SURGEON DID NOT HAVE FULL CONFIDENCE THAT HE HAD TIGHTENED THE CABLE AS WELL AS IT SHOULD BE TIGHTENED USING THE APPLICATOR AS PER THE SURGICAL TECHNIQUE GUIDE, BUT FELT THAT THE CABLE CONSTRUCT STILL HAD SOME RIGIDITY, AND COMPLETED THE PROCEDURE. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875170 ↗
• MalfunctionMay 16, 2023Break; Break

  THE DEVICE BROKE IN THE STERILE PROCESSING DEPARTMENT WHILE HANDLING AFTER CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939223 ↗
• MalfunctionMay 16, 2023Break; Break

  THE DEVICE BROKE IN THE STERILE PROCESSING DEPARTMENT WHILE HANDLING AFTER CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939211 ↗
• MalfunctionMay 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ZIPFIX APPLICATOR IN QUESTION WAS NO LONGER CRIMPING THE ZIPFIX IMPLANTS AS INTENDED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110789. One submission often covers many models, so check the product and lot details in each record.

• Z-0276-2016 · Oct 19, 2015 · Terminated
  Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum
• Z-2475-2015 · Jul 22, 2015 · Terminated
  Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to
• Z-0114-2014 · Aug 13, 2013 · Terminated
  Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to st