OMNISPAN ORTHOCORD 228142Recalls & reported problems
Medos International Sàrl · OMNISPAN MENISCAL REPAIR SYSTEM / 27 Degrees ORTHOCORD Violet braided composite suture, Size 2-0, (2) PEEK Backstops, and 27 Degrees (1) Curved Needle · Class 2 · Implant
All models of OMNISPAN ORTHOCORD (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos OMNISPAN meniscal repair system is a knee kit that uses a braided suture to stitch torn cartilage. Reports mostly describe parts that do not work together, devices deploying too early, and sutures breaking during tightening, and most report no harm to the patient. There are 910 reports, no deaths and 3 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
- 932
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 932 adverse event reports that list this exact device (DI 10886705010042), received between Jun 13, 2018 and Sep 30, 2026 — classified as 3 injuries, 929 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (312 reports).
5 other recalls cover devices cleared under the same FDA submission (K092836, K150209); they may or may not involve this specific model.
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 Incompatibility312
- Premature Activation254
- Break133
- Migration66
- Difficult to Advance59
- Detachment of Device or Device Component38
- Material Deformation34
- Positioning Failure28
Patient problems
- No Clinical Signs, Symptoms or Conditions816
- No Consequences Or Impact To Patient104
- Not Applicable5
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient2
- No Code Available1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 932 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952189 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952181 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952179 ↗MalfunctionSep 30, 2026Device-Device Incompatibility
It was reported that during an arthroscopic meniscal repair procedure the OMNISPAN MENISCAL REPAIR 27DEG device could not fire (deploy). 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. This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951660 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938086 ↗MalfunctionSep 29, 2026Difficult to Advance
It was reported that during a meniscal repair surgical procedure, while using the OMNISPAN MENISCAL REPAIR 27DEG anchor device, it was observed that the 2nd plate could not fix the meniscus after deployment. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935983 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935391 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934548 ↗MalfunctionSep 29, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934533 ↗MalfunctionSep 29, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930121 ↗MalfunctionSep 28, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923796 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920410 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920406 ↗MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920370 ↗MalfunctionSep 28, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917914 ↗MalfunctionSep 23, 2026Difficult to Advance
It was reported that during an arthroscopic meniscal repair procedure the OMNISPAN MENISCAL REPAIR 27DEG device, the plate could not fix int the meniscus after deployment. 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 50872402 ↗MalfunctionSep 21, 2026Break
It was reported that during Meniscal Repair surgery, the needle was broken off. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840954 ↗MalfunctionSep 18, 2026Premature Activation
It was reported that during a Meniscal Repair surgery, the OMNISPAN ORTHOCORD device double deployed. After the 1st firing, two plates were deployed at the same time. Another device was used to complete the procedure. 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 50818288 ↗MalfunctionSep 16, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794392 ↗MalfunctionSep 16, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793478 ↗MalfunctionSep 15, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778041 ↗MalfunctionSep 10, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721751 ↗MalfunctionSep 10, 2026Premature Activation
It was reported that during a meniscal repair surgical procedure, when using the OMNISPAN MENISCAL REPAIR 27DEG anchor device, after the 1st firing, two plates were deployed at the same time. It was reported that another device was used to complete the procedure. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713251 ↗MalfunctionSep 9, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698094 ↗MalfunctionSep 9, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698087 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092836, K150209. One submission often covers many models, so check the product and lot details in each record.
- Z-1680-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
- Z-1678-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
- Z-1681-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
- Z-1679-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
- Z-1677-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
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
- 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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