OMNISPAN ORTHOCORD 228141Recalls & reported problems

Summary

The FDA's MAUDE database contains 609 adverse event reports that list this exact device (DI 10886705010035), received between Feb 15, 2018 and Sep 29, 2026 — classified as 18 injuries, 591 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (204 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 609 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that during a cruciate ligament repair surgical procedure, when using the OMNISPAN MENISCAL REPAIR 12DEG anchor device it was observed that the needle was broken off. 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 50935541 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921685 ↗
• MalfunctionSep 28, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921652 ↗
• MalfunctionSep 28, 2026Device-Device Incompatibility

  It was reported that during a Meniscal Repair surgery, an OMNISPAN ORTHOCORD did not fire. Changed another three OMNISPAN ORTHOCORD needles and one MENISCAL DEPLOYMENT GUN 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 5 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920409 ↗
• MalfunctionSep 16, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785606 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that during ta meniscal repair surgical procedure, when using the OMNISPAN MENISCAL REPAIR 12DEG anchor device, after 1st firing, it was observed that the needle was detached from the meniscal gun. It was reported that the meniscal gun had no fault. 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 50770764 ↗
• MalfunctionSep 10, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717563 ↗
• MalfunctionSep 9, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698316 ↗
• MalfunctionSep 2, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571777 ↗
• MalfunctionSep 1, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539986 ↗
• MalfunctionAug 31, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527746 ↗
• MalfunctionAug 20, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50350623 ↗
• MalfunctionJul 27, 2026Device-Device Incompatibility; Material Deformation

  It was reported that during a meniscal repair surgical procedure, it was observed that the suture of the OMNISPAN MENISCAL REPAIR 12DEG device was winding, which lead to the device not firing. It was reported that the surgeon changed to another OMNISPAN MENISCAL REPAIR 12DEG device to continue the surgery, and the same problem happened again. 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 2 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034407 ↗
• MalfunctionMay 28, 2026Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE PLATE OF THE OMNISPAN ORTHOCORD DETACHED FROM THE MENISCUS AFTER DEPLOYMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314542 ↗
• MalfunctionMay 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE THE NEEDLE WAS DEFORMED. 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 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306676 ↗
• MalfunctionMay 27, 2026Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE DETACHED FROM 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 25304249 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE THE NEEDLE WAS DETACHED AT FIRST FIRING. 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 25288406 ↗
• MalfunctionMay 16, 2026Material Frayed; Material Deformation

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SUTURE OF THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE WAS WINDING. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE SUTURE WAS DETACHED FROM THE NEEDLE, TANGLED AND FRAYED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195130 ↗
• MalfunctionMay 7, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE OMNISPAN ORTHOCORD DEVICE PLATE DETACHED IN THE PACKAGING. OPENED THE PACKING (DID NOT USE), NOTED THE PLATE WAS DETACHED (AS THE ATTACHED. ANOTHER LIKE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113923 ↗
• MalfunctionMay 5, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THAT THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE ANCHOR DETACHED FROM THE MENISCUS AFTER INSERTED. 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 25085849 ↗
• MalfunctionMay 5, 2026Premature Activation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE HAD BOTH PLATES DEPLOYED AT THE SAME TIME. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5 MINUTE 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 25084887 ↗
• MalfunctionApr 28, 2026Premature Activation

  IT WAS REPORTED THAT DURING THE MENISCAL REPAIR SURGERY WITH AN OMNISPAN MENISCAL REPAIR 12DEG DEVICE, AFTER THE FIRST FIRING, TWO PLATES WERE DEPLOYED AT THE SAME TIME. 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 25017246 ↗
• MalfunctionApr 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MENISCAL REPAIR SURGERY, A MENISCAL DEPLOYMENT GUN AND AN OMNISPAN ORTHOCORD COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A TEN MINUTE DELAY. 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 24804802 ↗
• MalfunctionApr 2, 2026Premature Activation

  IT WAS REPORTED THAT DURING MENISCAL REPAIR SURGERY, AFTER 1ST FIRING OF THE OMNISPAN ORTHOCORD DEVICE, TWO PLATES WERE DEPLOYED AT THE SAME TIME. 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 24766096 ↗
• MalfunctionMar 26, 2026Premature Activation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THAT THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE, THAT DURING THE SURGERY, AFTER 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 ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702514 ↗

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-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy 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, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy 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, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724