Arthrex® AR-4501Recalls & reported problems
Arthrex, Inc. · MENISCAL CINCH™ II · Class 2 · Implant
Quick summary
This Arthrex Meniscal Cinch II is a knee meniscus repair device that uses a suture. Many of its 396 adverse event reports describe parts breaking, the device coming loose, or the push button sticking and failing to deploy. The reports list 67 injuries and no deaths, and no recalls name this device. Reports fell from 89 in the prior 12 months to 12 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 403
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 00888867299139), received between Jan 30, 2019 and Sep 29, 2026 — classified as 67 injuries, 336 malfunctions.
The most frequently reported specific device problem is “Break” (146 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.
Reports received per month
Most reported problems
Device problems
- Break146
- Device Dislodged or Dislocated81
- Failure to Advance50
- Physical Resistance/Sticking40
- Material Split, Cut or Torn17
- Material Twisted/Bent16
- Detachment of Device or Device Component13
- Mechanical Jam12
Patient problems
- No Clinical Signs, Symptoms or Conditions256
- Insufficient Information85
- No Known Impact Or Consequence To Patient26
- Failure of Implant15
- Foreign Body In Patient11
- Device Embedded In Tissue or Plaque6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- No Information3
Recent adverse event reports
The 25 most recent of 403 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933036 ↗MalfunctionSep 18, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820414 ↗MalfunctionSep 18, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820275 ↗MalfunctionSep 17, 2026Device Dislodged or Dislocated
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 3 units of AR-4501, Meniscal Cinch¿ II:The first unit of AR-4501's anchor dropped out when the suture was tightened. A 2nd AR-4501 was changed to but both anchors dropped out too. A 3rd AR-4501 was used but the second anchor dropped out again.This was detected during a knee meniscus repair surgery on (b)(6) 2026. The procedure was completed successfully by using a 4th AR-4501. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803256 ↗MalfunctionSep 17, 2026Device Dislodged or Dislocated
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 3 units of AR-4501, Meniscal Cinch¿ II:The first unit of AR-4501's anchor dropped out when the suture was tightened. A 2nd AR-4501 was changed to but both anchors dropped out too. A 3rd AR-4501 was used but the second anchor dropped out again.This was detected during a knee meniscus repair surgery on (b)(6) 2026. The procedure was completed successfully by using a 4th AR-4501. There were no patient harm and no secondary procedure needed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803254 ↗MalfunctionSep 17, 2026Device Dislodged or Dislocated
On 3rd September 2026, it was reported by an Arthrex's employee via an Email that for 3 units of AR-4501, Meniscal Cinch¿ II:The first unit of AR-4501's anchor dropped out when the suture was tightened. A 2nd AR-4501 was changed to but both anchors dropped out too. A 3rd AR-4501 was used but the second anchor dropped out again.This was detected during a knee meniscus repair surgery on (b)(6) 2026. The procedure was completed successfully by using a 4th AR-4501. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803249 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756681 ↗MalfunctionAug 17, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277180 ↗MalfunctionAug 14, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252702 ↗MalfunctionAug 13, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241045 ↗MalfunctionAug 10, 2026Physical Resistance/Sticking
It was reported that during the anterior cruciate ligament surgery, the trigger mechanism did not click into place on the plastic and did not lock. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50200868 ↗MalfunctionAug 4, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129082 ↗MalfunctionApr 15, 2026Physical Resistance/Sticking
ON 27TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS AR-4501, MENISCAL CINCH¿ II, THE FIRST BUTTON COULD NOT BE PUSHED, THEN A NEW AR-4501 WAS USED, BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING USE IN A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD ONE. NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. KNOT PUSHER AND CUTTER PART NUMBER IS AR-11790. 1ST APRIL 2026 - THE COMPLAINT INITIATOR REPLIED THAT THE DEFECT WAS DISCOVERED WHILE THE DEVICE WAS IN THE PATIENT. THE IMPLANT DID NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887168 ↗MalfunctionMar 30, 2026Physical Resistance/Sticking
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE FIRST BUTTON WAS STUCK AND IMPLANT FAILED TO DEPLOY. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713617 ↗MalfunctionJan 23, 2026Physical Resistance/Sticking
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE PUSH BUTTON OF THE FIRST IMPLANT WAS STUCK. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159844 ↗MalfunctionDec 23, 2025Positioning Failure; Physical Resistance/Sticking; Positioning Failure; Physical Resistance/Sticking
ON 3RD DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE FIRST IMPLANT FIXED SUCCESSFULLY BUT WHEN SETTING THE SECOND IMPLANT, THE BUTTON COULD NOT BE RETRIEVED. THE SUTURE WAS STUCK AS WELL. THIS WAS DETECTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF TIBIAL FRACTURES WITH PLATES SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881366 ↗MalfunctionDec 17, 2025Break; Break
ON 27TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE FIRST IMPLANT WAS SET PROPERLY HOWEVER THE SECOND IMPLANT WAS BROKEN. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827716 ↗MalfunctionNov 24, 2025Positioning Failure; Positioning Failure
ON 4TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE FIRST IMPLANT WAS SET PROPERLY BUT THE SECOND IMPLANT COULD NOT BE SET. THIS WAS DETECTED DURING AN ARTHROSCOPIC PATELLA RESHAPING, LEFT KNEE MENISCUS SUTURING SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630289 ↗MalfunctionNov 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 3RD NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, THE FIRST IMPLANT WAS SET PROPERLY BUT WHEN TRIGGERED THE SECOND IMPLANT, THE BUTTON WAS STUCK. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND MENISCUS INJURY PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618252 ↗MalfunctionOct 27, 2025Break; Break
ON 15TH OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 3 UNITS OF AR-4501, MENISCAL CINCH¿ II, BOTH IMPLANTS WERE SET PROPERLY BUT THE SUTURE BROKE WHEN USING THE KNOT PUSHER. ANOTHER TWO NEW AR-4501 WERE OPENED BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCT. THERE WERE NO PATIENT HARM OR SECONDARY PROCEDURE NEEDED. PLEASE NOTE: THIS CASE WAS CREATED BECAUSE THE ORIGINAL CASE (B)(4) ENCOUNTERED SYSTEM ISSUES DURING THE UPDATE PROCESS. AS A RESULT, IT VOIDED THE ORIGINAL CASE, AND A NEW CASE (B)(4) WAS CREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392412 ↗MalfunctionOct 27, 2025Break; Break
ON 15TH OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 3 UNITS OF AR-4501, MENISCAL CINCH¿ II, BOTH IMPLANTS WERE SET PROPERLY BUT THE SUTURE BROKE WHEN USING THE KNOT PUSHER. ANOTHER TWO NEW AR-4501 WERE OPENED BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCT. THERE WERE NO PATIENT HARM OR SECONDARY PROCEDURE NEEDED. PLEASE NOTE: THIS CASE WAS CREATED BECAUSE THE ORIGINAL CASE (B)(4) ENCOUNTERED SYSTEM ISSUES DURING THE UPDATE PROCESS. AS A RESULT, IT VOIDED THE ORIGINAL CASE, AND A NEW CASE (B)(4) WAS CREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392314 ↗MalfunctionOct 27, 2025Break; Break
ON 15TH OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 3 UNITS OF AR-4501, MENISCAL CINCH¿ II, BOTH IMPLANTS WERE SET PROPERLY BUT THE SUTURE BROKE WHEN USING THE KNOT PUSHER. ANOTHER TWO NEW AR-4501 WERE OPENED BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCT. THERE WERE NO PATIENT HARM OR SECONDARY PROCEDURE NEEDED. PLEASE NOTE: THIS CASE WAS CREATED BECAUSE THE ORIGINAL CASE (B)(4) ENCOUNTERED SYSTEM ISSUES DURING THE UPDATE PROCESS. AS A RESULT, IT VOIDED THE ORIGINAL CASE, AND A NEW CASE (B)(4) WAS CREATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392176 ↗MalfunctionOct 23, 2025Failure to Advance; Failure to Fire; Failure to Advance; Failure to Fire
IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY THE TRIGGER GOT LOCKED AND IT WAS NOT POSSIBLE TO FIRE INTO THE MENISCUS. SOME PARTS BROKE OFF AND COULD BE RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369477 ↗MalfunctionAug 29, 2025Failure to Fire; Failure to Fire
ON 08/12/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-4501 MENISCAL CINCH II EXPERIENCED AN ISSUE DURING ITS SECOND SUTURE DEPLOYMENT, IN WHICH THE IMPLANT WAS NOT RELEASED. NO ADDITIONAL DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/18/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921754 ↗MalfunctionAug 20, 2025Break; Failure to Advance; Device Dislodged or Dislocated; Break; Failure to Advance; Device Dislodged or Dislocated
ON 4TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-4501, MENISCAL CINCH¿ II, BOTH IMPLANTS WERE DEPLOY AND SET PROPERLY, WHEN RETRIEVING THE SUTURE, IT BROKE, AND BOTH IMPLANTS WAS PULLED OUT. THIS WAS DETECTED DURING A MENISCUS REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4501. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854564 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.