TRUESPAN ORTHOCORD 228151Recalls & reported problems
Medos International Sàrl · TRUESPAN Meniscal Repair System PEEK 12 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PEEK Backstops, and (1) Applier with 12 DEGREES needle Depth Stop: 10mm-20mm Plus or Minus 1mm; Needle: 10mm Plus or Minus .13mm · Class 2 · Implant
All models of TRUESPAN ORTHOCORD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the TrueSpan OrthoCord meniscal repair system, a suture kit used in arthroscopic knee surgery. The 1,664 reports often describe parts breaking during surgery, two plates deploying at once, and devices not fitting with other parts. Some describe the device not releasing. The records include no deaths, 58 injuries and 1,606 malfunctions, and no recalls name this device.
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
- 1,686
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,686 adverse event reports that list this exact device (DI 10886705026012), received between Dec 28, 2017 and Sep 30, 2026 — classified as 58 injuries, 1,628 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (703 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility703
- Break326
- Premature Activation121
- Migration96
- Positioning Failure95
- Mechanical Jam82
- Difficult to Advance78
- Detachment of Device or Device Component75
Patient problems
- No Clinical Signs, Symptoms or Conditions1,195
- No Consequences Or Impact To Patient313
- Not Applicable142
- Unspecified Tissue Injury23
- Foreign Body In Patient21
- No Code Available19
- Tissue Damage14
- No Known Impact Or Consequence To Patient13
Recent adverse event reports
The 25 most recent of 1,686 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Activation
It was reported that when the first shot of the TRUESPAN ORTHOCORD was fired, the device activated and released both shots. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943821 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938839 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938838 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938835 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938833 ↗MalfunctionSep 29, 2026Device-Device Incompatibility; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935263 ↗MalfunctionSep 29, 2026Device-Device Incompatibility; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935254 ↗MalfunctionSep 29, 2026Break; Unintended Movement; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934167 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933673 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933494 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933488 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that during a meniscal repair surgical procedure, when using the TRUESPAN 12 DEGREE PEEK device, it was observed that the device could not fire. It was reported that the surgeon attempted to use 2X additional TRUESPAN 12 DEGREE PEEK devices to continue the surgery, but the same problem happened again with both devices. It was reported that another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided. This is report 1 of 3 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899806 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that during a meniscal repair surgical procedure, when using the TRUESPAN 12 DEGREE PEEK device, it was observed that the device could not fire. It was reported that the surgeon attempted to use 2X additional TRUESPAN 12 DEGREE PEEK devices to continue the surgery, but the same problem happened again with both devices. It was reported that another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899803 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that during a meniscal repair surgical procedure, when using the TRUESPAN 12 DEGREE PEEK device, it was observed that the device could not fire. It was reported that the surgeon attempted to use 2X additional TRUESPAN 12 DEGREE PEEK devices to continue the surgery, but the same problem happened again with both devices. It was reported that another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.This is report 3 of 3 for (b)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899802 ↗MalfunctionSep 21, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846147 ↗MalfunctionSep 16, 2026Difficult to Advance
It was reported that during a Meniscal Repair surgery, the second plate of the TRUESPAN ORTHOCORD did not fix the meniscus after deployment. Changed to another TRUESPAN ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791086 ↗MalfunctionSep 16, 2026Difficult to Advance
It was reported that during a Meniscal Repair surgery, the second plate of the TRUESPAN ORTHOCORD did not fix the meniscus after deployment. Changed to another TRUESPAN ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791085 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790109 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790087 ↗MalfunctionSep 16, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787768 ↗MalfunctionSep 16, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787700 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787244 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
It was reported that during a Meniscal Repair surgery, a TRUESPAN ORTHOCORD did not fire. Changed to another two TRUESPAN ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787242 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787240 ↗MalfunctionSep 16, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787036 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
- TWINFIX 72202595Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE446 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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