TRUESPAN ORTHOCORD 228161Recalls & reported problems
Medos International Sàrl · TRUESPAN Meniscal Repair System PLGA 12 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PLGA 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 Medos TRUESPAN Orthocord is a soft tissue fastener and suture system for meniscal repair. Its 407 adverse event reports often describe parts not fitting together, breakage, and anchors that will not advance, and some mention the device moving out of place. The reports include no deaths and 10 injuries. 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
- 419
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 419 adverse event reports that list this exact device (DI 10886705026043), received between Oct 21, 2019 and Sep 29, 2026 — classified as 11 injuries, 408 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (206 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 Incompatibility206
- Break101
- Difficult to Advance33
- Migration29
- Detachment of Device or Device Component28
- Physical Resistance/Sticking18
- Mechanical Jam15
- Packaging Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions395
- No Consequences Or Impact To Patient10
- Unspecified Tissue Injury7
- Foreign Body In Patient2
- No Code Available2
- Not Applicable2
- Tissue Damage2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 419 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device-Device Incompatibility; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934843 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915275 ↗MalfunctionSep 25, 2026Use of Device Problem; Device-Device Incompatibility
It was reported that during an unknown surgery, the TRUESPAN ORTHOCORD device could not be fired. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895494 ↗MalfunctionSep 21, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847031 ↗MalfunctionSep 21, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846753 ↗InjurySep 21, 2026Detachment of Device or Device Component
Patient problems: Unspecified Tissue Injury
MAUDE report 50846278 ↗MalfunctionSep 21, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844061 ↗MalfunctionSep 18, 2026Device-Device Incompatibility
It was reported that during meniscal repair surgery, the TRUESPAN ORTHOCORD device failed to fire when the gun was triggered. A new Truespan was opened and the procedure continued smoothly. There was no delay in the procedure reported. 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 50818462 ↗MalfunctionSep 16, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794897 ↗MalfunctionSep 15, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777830 ↗MalfunctionSep 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722324 ↗MalfunctionSep 9, 2026Device-Device Incompatibility
It was reported that during an unspecified procedure, two TRUESPAN ORTHOCORD devices did not fire correctly, and they were not able to be used. User is very experienced. Patient was not harmed in any way and no particles left in the patient. The delay was approximately seven minutes. All available information has been disclosed. This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694351 ↗MalfunctionSep 9, 2026Device-Device Incompatibility
It was reported that during an unspecified procedure, two TRUESPAN ORTHOCORD devices did not fire correctly, and they were not able to be used. User is very experienced. Patient was not harmed in any way and no particles left in the patient. The delay was approximately seven minutes. All available information has been disclosed. This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694344 ↗MalfunctionSep 2, 2026Crack; Device Damaged Prior to Receipt by User; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572733 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568686 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568418 ↗MalfunctionSep 2, 2026Device Damaged Prior to Receipt by User; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563464 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503032 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439607 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439606 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439604 ↗MalfunctionAug 24, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419176 ↗MalfunctionAug 24, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419175 ↗MalfunctionJul 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090534 ↗MalfunctionJul 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057183 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- 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
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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