DYNACORD 222073Recalls & reported problems
Medos International Sàrl · DYNACORD Suture 1 Blue and 1 White/Blue/Green Striped Braided Composite Suture OS-6 36mm 1/2c Reverse Cutting N=2 Number 2 (5 metric), 36 inches (91 cm) · Class 2 · Implant
All models of DYNACORD (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20886705030054), received between Jun 10, 2021 and Jul 13, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗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 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
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- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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