FAST-FIX 72201494Recalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 03596010597229), received between Oct 12, 2017 and Mar 23, 2026 — classified as 102 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (95 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); 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 249 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Failure to Fire; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC MENISCUS REPAIR, THE SECOND T OF AN ULTRA FAST-FIX FAILED TO DEPLOY. THE T WAS REMOVED WITH GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663412 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T1 IMPLANT OF ONE (1) ULTRA FAST-FIX CURVED BROKE IN HALF UPON TENSIONING THE REPAIR: THE T2 IMPLANT WAS LEFT SECURED IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24179772 ↗
• MalfunctionJan 26, 2026Premature Activation

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T2 IMPLANT OF ONE (1) ULTRA FAST-FIX CURVED CAME OFF THE INSERTER WHEN TRYING TO ADVANCE IT TO THE DEPLOYMENT POSITION, THE T1 IMPLANT WAS LEFT SECURED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24179678 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE T1 IMPLANT OF ONE (1) ULTRA FAST-FIX CURVED WAS RIPPED OFF THE INSERTER AND WAS REMOVED FROM THE PATIENT WITH A SHAVER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179634 ↗
• MalfunctionDec 29, 2025Device Dislodged or Dislocated; Firing Problem; Device Dislodged or Dislocated; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, WHEN T1 WAS FIRED FROM ONE (1) ULTRA FAST-FIX, BOTH TS CAME OUT. T1 WAS DEPLOYED THROUGH THE MENISCUS. BOTH TS WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919040 ↗
• MalfunctionDec 29, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, WHEN T1 WAS FIRED FROM ONE (1) ULTRA FAST FIX, BOTH TS CAME OUT. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905933 ↗
• MalfunctionOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS SUTURE SURGERY, WHEN TIGHTENING THE SUTURE, THE T1 OF THE ULTRA FAST FIX WAS DISLODGED FROM THE MENISCUS. T2 IMPLANT WAS REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING A SN BACK-UP. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415742 ↗
• MalfunctionOct 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS SUTURE SURGERY, WHEN TIGHTENING THE SUTURE, THE T1 OF THE ULTRA FAST FIX WAS DISLODGED FROM THE MENISCUS. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415643 ↗
• MalfunctionOct 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS ARTHROSCOPIC REPAIR, THE UTRA FAST-FIX THREAD SEEMS TO HAVE EITHER BEEN TORN OR NOT ATTACHED FROM THE BEGINNING, BECAUSE THE THREAD AND T2 CAME OUT OF THE JOINT TOGETHER. THE T2 WAS REMOVED, AND THE T1 REMAINED SECURED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A FAST-FIX 360 AS THE BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23334029 ↗
• MalfunctionJun 5, 2025Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSPECTION (1) ULTRA-FAST FIX HAD DETERIORATED, T1 HAD BEEN CUT FROM THE SUTURE. T2 WAS DEFORMED AND FRAGMENTED ON THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150006 ↗
• MalfunctionJan 13, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, SEVEN (7) ULTRA FAST-FIX DEVICES CONSECUTIVELY EXPERIENCED PREMATURE DEPLOYMENT OF THE TS. THREE (3) DEVICES FAILED INTERNAL TO THE PATIENT. OF THE THREE (3) FAT FIX THAT FAILED INSIDE THE PATIENT, FIVE T-IMPLANTS WERE LEFT SECURED IN THE PATIENT IN TOTAL. THREE T1 AND TWO T2. NO T-IMPLANTS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21139074 ↗
• MalfunctionDec 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE ULTRA FAST-FIX CURVED T2 DID NOT TRIGGER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875375 ↗
• MalfunctionDec 7, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE T2 OF THE ULTRA FAST-FIX DID NOT TRIGGER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20874167 ↗
• MalfunctionDec 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ULTRA FAST FIX T2 DID NOT TRIGGER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859154 ↗
• MalfunctionNov 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 IMPLANT OF THE ULTRA FAST FIX PULLED OUT AFTER DEPLOYING T2. BOTH T'S WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700561 ↗
• MalfunctionOct 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS PROCEDURE, THE T2 OF TWO (2) UNITS OF THE ULTRA FAST-FIX CURVED WERE DISLODGED IN THE MENISCUS. NONE OF THE T-IMPLANTS WERE SECURED IN THE PATIENT, AND T1 WAS SUCCESSFULLY REMOVED WITH TWEEZERS. THERE WAS A BACK-UP DEVICE AVAILABLE, AND THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446580 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST FIX ONE SIDE OF THE T IMPLANT FOR THE SECOND DEVICE WAS INCOMPLETE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739894 ↗
• MalfunctionJul 1, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, TWO ULTRA FAST-FIX FAILED IN THE SAME WAY. THE T2 WAS STUCK AND COULD NOT BE DEPLOYED, THE T1 WAS REMOVED DIRECTLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646163 ↗
• MalfunctionJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LIGAMENT SURGERY, THE T1 AND T2 IMPLANTS OF THE ULTRA FAST FIX FELL OFF WHEN THE SUTURE KNOT WAS TIGHTENED. BOTH T IMPLANTS WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A STARSPORTMED COMPETITOR DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620457 ↗
• MalfunctionJun 17, 2024Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRA FAST-FIX BROKE, QUALITY ISSUES WERE REPORTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548086 ↗
• MalfunctionJun 14, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE T1 IMPLANT OF TWO (2) ULTRA FAST-FIX DEVICES RECEDED DURING DEPLOYMENT, MULTIPLE ATTEMPTS BUT STILL FAILED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538355 ↗
• MalfunctionJun 12, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, AFTER THE ULTRA FAST-FIX T1 WAS IMPLANTED, THE T2 IMPLANT COULD NOT BE DEPLOYED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520422 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, TWO(2) ULTRA FAST-FIX DEVICES PRESENTED A FAILURE, THE T IMPLANT OF BOTH DEVICES WAS FOUND TO BE INCOMPLETE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520360 ↗
• MalfunctionJun 3, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING ARTHROSCOPY, THE T2 OF A ULTRA FAST-FIX COULD NOT BE DEPLOYED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455345 ↗
• MalfunctionMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, A FAST FIX T2 FAILED TO IMPLANTED NORMALLY. SURGERY RESUMED WITH A BACK-UP DEVICE; HOWEVER IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305137 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• Z-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0170-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165

…and 25 more.