ORTHOCORD 228145Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705010073), received between Apr 24, 2020 and Dec 12, 2025 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NIT MENSCL SUT NDL W2-0 OC 5PK DEVICE WAS MISSING COMPONENTS. IT WAS REPORTED IN THE SERVICE ORDER THAT PRIOR TO A MENISCAL REPAIR SURGERY IT WAS OBSERVED THAT THE DEVICE WAS MISSING FEATURES. 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 23795481 ↗
• MalfunctionDec 5, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 2-0 ORTHOCORD (3 FREE STRANDS) W/MENISCAL NEEDLE AND THE TRUESPAN MENISCAL REPAIR SYSTEM PEEK 12 DEGREE DEVICES WERE BROKEN WHILE IN USE TOGETHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914997 ↗
• MalfunctionApr 24, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN ARTHROSCOPY WHEN THE PACKAGE OF THE NIT MENSCL SUT NDL W2-0 OC 5PK WAS OPENED IT WAS NOTED THAT THE SUTURE THAT NORMALLY COME IN AN ENVELOPE, WERE NOT INSIDE ONLY THE NIT MENSCL SUT NDL W2-0 OC 5PK. IT WAS FURTHER REPORTED THAT THE PACKAGE WAS SEALED AND NOT DAMAGED AND THE SECURITY SEAL WAS NOT BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SILVER INNER PACKAGE WAS RECEIVED WITHOUT THE NEEDLE NOR THE NEEDLE PACKAGE. IT WAS NOT REPORTED IF THERE WAS A DELAY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9997494 ↗