Infinity AIM KMR2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20845854649906), received between Oct 30, 2024 and Jan 13, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (5 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Failure to Fire

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿SURGEON HAD TWO FAILURES USING ITEM KMR2S LOTS 1486323 & 1503195. BOTH FAILURES HAPPENED WHEN TENSIONING THE 2ND IMPLANT AFTER DEPLOYMENT. PATIENT WAS UNHARMED AND CASE WAS DELAYED 4 MINS.¿. FURTHER ASSESSMENT FOUND THE "IMPLANT PULLED THROUGH THE CASPULE WHEN TENSIONING". THE "FIRST IMPLANT SEATED CORRECTLY" AND "IMPLANTS WERE REMOVED ON THE FAILED INSTRUMENTS" DUE TO A FAILED DEPLOYMENT OF THE SUBSEQUENT IMPLANT. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 24055489 ↗
• MalfunctionDec 29, 2025Failure to Fire; Failure to Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED WAS BEING USED ON (B)(6) 2025 AND THE ¿¿DEVICES WERE USED WITH PROPER SURGICAL TECHNIQUE AND BOTH FAILED. THE PATIENT WAS UNHARMED. SURGERY WAS DELAYED 3 MINUTES. REPAIR WAS COMPLETED USING STRYKER AIR.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "FIRST IMPLANT DEPLOYED PROPERLY. 2ND IMPLANT FAILED AFTER DEPLOYMENT. SURGEON REMOVED THE IMPLANT. THIS OCCURRED TWICE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905304 ↗
• MalfunctionDec 29, 2025Failure to Fire; Failure to Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED WAS BEING USED ON (B)(6) 2025 AND THE ¿¿DEVICES WERE USED WITH PROPER SURGICAL TECHNIQUE AND BOTH FAILED. THE PATIENT WAS UNHARMED. SURGERY WAS DELAYED 3 MINUTES. REPAIR WAS COMPLETED USING STRYKER AIR.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "FIRST IMPLANT DEPLOYED PROPERLY. 2ND IMPLANT FAILED AFTER DEPLOYMENT. SURGEON REMOVED THE IMPLANT. THIS OCCURRED TWICE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905303 ↗
• MalfunctionDec 29, 2025Failure to Fire; Failure to Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED WAS BEING USED ON 5DEC25 AND THE ¿¿DEVICES WERE USED WITH PROPER SURGICAL TECHNIQUE AND BOTH FAILED. THE PATIENT WAS UNHARMED. SURGERY WAS DELAYED 3 MINUTES. REPAIR WAS COMPLETED USING STRYKER AIR.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "FIRST IMPLANT DEPLOYED PROPERLY. 2ND IMPLANT FAILED AFTER DEPLOYMENT. SURGEON REMOVED THE IMPLANT. THIS OCCURRED TWICE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905300 ↗
• InjuryDec 3, 2025Failure to Fire; Failure to Fire

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED, WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿AFTER PLACING THE FIRST IMPLANT THE SURGEON BACKS THE NEEDLE ABOUT 1CM, WHEN DOING THIS THE SECOND IMPLANT DISLODGED WITHOUT FIRING A SECOND TIME. THE DEVICE WAS NOT FIRED A SECOND TIME, THE EVIDENCE FOR THIS CLAIM IS THAT THE PUSHROD WAS NOT YET DEPLOYED IN FRONT OF THE NEEDLE. IT WAS STILL INSIDE THE NEEDLE.¿. THE REPORT ALSO STATED, ¿UNNECESSARY DAMAGE TO THE MENISCUS.¿. FURTHER ASSESSMENT FOUND THAT ¿THERE WAS MORE DAMAGE THEN JUST THE PUNCTURING OF THE NEEDLE. THE FIRST IMPLANT WAS SUCCESSFUL, BUT THE DEVICE FAILED WHEN THE SURGEON TRIED TO CREATE ENOUGH SLACK FOR THE SECOND IMPLANT, AROUND 1CM. WHEN SHE DID THIS THE SECOND IMPLANT JUST DISLODGED. THE PUSHROD DIDN¿T COVER THE NEEDLE SO I KNOW THAT THE SURGEON DIDN¿T PUSH TWICE. WHEN REMOVING THE FIRST IMPLANT THE HOLE IN THE MENISCUS BECAME BIGGER. THIS PART IS OUTSIDE THE NORMAL USE, THE MALFUNCTION OF THE DEVICE FORCED THE SURGEON TO REMOVE THE IMPLANT.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HO

  Patient problems: Laceration(s)

  MAUDE report 23703503 ↗
• InjuryJun 6, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURVED, WAS BEING USED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, "BASICALLY THE SECOND IMPLANT APPEARS NOT TO HAVE BEEN CONNECTED TO THE SUTURE OR IT DEPLOYED EARLY. AGAIN, THE SURGEON HAD TO SEARCH FOR THE IMPLANTS BEHIND THE KNEE BUT HE COULD ONLY FIND ONE.¿. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A 5-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22157311 ↗
• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE KMR2S, INFINITY AIM MENISCAL REPAIR DEVICE, 25° CURED, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A KNEE ARTHROSCOPY MEDIAL MENISCUS REPAIR PROCEDURE WHEN IT WAS REPORTED ¿THE SURGEON PIERCED THE MENISCUS AND WENT TO THE OTHER SIDE THE FIRST IMPLANT DEPLOYED SUCCESSFULLY, HE PULLED OUT THE NEEDLE AND PIERCED THE SECOND TIME THE MENISCUS AND WHEN HE TRIED TO DEPLOY THE SECOND IMPLANT IT DIDN¿T FIRE AND THE TRIGGER GOT STUCK, AND SECOND BUTTON DIDN¿T COME THROUGH AFTER MULTIPLE ATTEMPTS, FAILED TO DEPLOY SECOND IMPLANT. IT HAPPENED WITH 2 DEVICES AND THE THIRD ONE SUCCESSFULLY DEPLOYED THE 2 IMPLANTS BUT BUTTON CAME OUT FROM THE MENISCUS AND IT WAS BROKEN.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿WHEN HE WAS TENSIONING THE SUTURES AFTER THE DEPLOYMENT OF BOTH THE IMPLANTS, THE SECOND BUTTON PULLED OUT FROM THE MENISCUS AND IT WAS BROKEN FROM THE MIDDLE, SO DOCTOR REMOVED IT THROUGH GRASPER AND PUNCH. HE COMPLETELY REMOVED THE PEEK BUTTON FROM THE SURGICAL SITE. THE DEVICE RETRIEVED SUCCESSFULLY WITHOUT ANY DEBRIS AND COMPLICATIONS. GRASPER, SUTURE CUTTER, AND PUNCH WAS USED TO RETRIEVE THE DEVICE FROM THE SURGICAL SITE.". THE PROCEDURE WAS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565638 ↗