DYNACORDRecalls & reported problems across all models

We found 6 models of DYNACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2020 and Jul 13, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DYNACORD problems

DYNACORD models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DYNACORD 222065

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  8 reports
• DYNACORD 222071

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  4 reports
• DYNACORD 222069

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• DYNACORD 222073

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• DYNACORD 222066

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports
• DYNACORD 222067

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent DYNACORD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SEPTIC INFECTION AFTER ACL (ANT.CRUCIATE LIGAMENT) RECONSTRUCTION SURGERY WHERE J&J IMPLANTS (DYNACORD X1, SPEEDTRAP X4, MILAGRO X1, RIGIDLOOP X1, ABSOLUTE X1) WERE UTILIZED. THE INITIAL ACL CASE TOOK PLACE ON (B)(6) 2026. DURING THE CASE, THERE WAS NO NOTABLE INCIDENT OBSERVED, ALL PROCEDURES FOLLOWED HOSPITAL POLICY AND THE CASE DURATION WAS APPROXIMATELY 1.5 HOURS. AFTER SURGERY, PATIENT VISITED THE SURGEON FOR CONSULTATION AND SURGEON PRESCRIBED ANTIBIOTICS AND CLEANED WOUND. AS SITUATION WAS NOT IMPROVED, A SECOND SURGERY WAS ARRANGED ON (B)(6) 2026 TO REMOVE ALL IMPLANTS AND WASHED THE JOINT WITH ANTIBIOTICS. ALL IMPLANTS WERE DISCARDED ON (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25796227 ↗
• MalfunctionJun 8, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A POST MARKET COMPLICATION OCCURRED DUE TO INTRA OP DEVICE BREAKAGE OF A DYNACORD MULTIPAK W/O NDL DEVICE DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY. THE DEVICE HAD BEEN USED WITH THE FMS VUE II SYSTEM AND THE VAPR SYSTEM. THE DEVICE WAS REMOVED AND REPLACED INTRA OPERATIVELY. NO ADDITIONAL IMPACT TO THE PATIENT OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25433811 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR AN ACHILLES TENDON REPAIR, THE SURGEON FOUND THAT THE DYNACORD MULTIPAK W/OS-6 NDL SUTURE DEVICE WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS GENERATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281617 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE, THE SURGEON WAS USING THE FREE STRAND DYNACORD BLUE W/MO-7 NDL 12PK DEVICE WITH A NEEDLE DURING AN OPEN PROCEDURE AND WHILE WHIP STITCHING A GRAFT IN PLACE THE NEEDLE CAME FLYING OFF THE SUTURE. THERE WERE NO AGGRESSIVE MOVEMENTS DURING THIS ACTION AND IT WAS NOTED THAT THE NEEDLE CAME OFF THE FREE STRAND SUTURE VERY EASILY. A COMPETITIVE SUTURE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893076 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNKNOWN SURGICAL PROCEDURE WITH PHILOS PERFORMED. ON (B)(6) 2024 THE DYNACORD BLUE W/MO-7 NDL 12PK DEVICE WAS APPLIED TO THE ROTATOR CUFF, THE NEEDLE PART WAS PULLED FORCEFULLY. HOWEVER, THE NEEDLE CAME OFF FROM THE SUTURE, AND THE NEEDLE LEFT IN THE BODY TEMPORARY. THE IMAGE WAS USED IMMEDIATELY, AND IT WAS ALSO VISIBLE. THE NEEDLE WAS REMOVED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689302 ↗
• MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 1 OF 5 FOR PC-(B)(4).. IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DYNACORD MULTIPAK W/O NDL DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657489 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE DYNACORD MULTIPAK DEVICE SUTURES SNAPPED DURING TENSIONING MID SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712112 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT IN THE MIDDLE OF AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE DYNACORD MULTIPAK DEVICE SUTURES SNAPPED DURING TENSIONING MID SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712107 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THREE DYNACORD SUTURES SNAPPED WHILE TENSIONING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672628 ↗
• InjuryAug 31, 2023Break; Break

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, A DYNACORD¿ SUTURES (BLUE, WHITE/BLUE/GREEN), NO NEEDLES. MULTI (12) PACK. DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17662388 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2022 USING A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE DEVICE AND DYNACORD¿ SUTURES, WITH MO-7 NEEDLES DEVICE, THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS THAT RESULTED IN RE-OPERATION/REVISIONS. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15919413 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN OPEN BICEPS TENODESIS PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE NEEDLE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 DEVICE WAS POPPING OFF WHILE WHIP STITCHING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372982 ↗
• MalfunctionSep 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HIP PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NEEDLE DETACHED FROM THE SUTURE ON THE DYNACORD BLUE W/OS-6 NDL DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432756 ↗
• MalfunctionJun 10, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP IN (B)(6) DURING A HIP PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NEEDLE ON THE DYNACORD¿ SUTURES (BLUE, WHITE/BLUE/GREEN), WITH OS-6 NEEDLES. MULTI (12) PACK WAS LOOSE AND NOT WELL ATTACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978135 ↗
• MalfunctionMay 6, 2021Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT EVERY SECOND SUTURE ON THE DYNACORD¿ SUTURE (BLUE), WITH OS-6 NEEDLE MULTI (12) PACK DEVICE WOULD TEAR FROM THE SUTURE WHILE CLOSING THE SKIN. THE SURGEON STATED THAT HE DID NOT PULL STRONGLY ON THE NEEDLE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787312 ↗

Other Medos International Sàrl products

• TRUESPAN ORTHOCORD6 models · 4,109 reports
• FMS39 models · 3,588 reports
• EXPEDIUM291 models · 3,312 reports
• EXPEDIUM VERSE90 models · 2,686 reports
• EXPRESSEW6 models · 2,459 reports
• OMNISPAN ORTHOCORD3 models · 1,581 reports
• HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
• PROWLER SELECT9 models · 1,066 reports