GII QUICKANCHOR ORTHOCORD 222983Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10886705008612), received between Mar 13, 2018 and Sep 28, 2026 — classified as 13 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (76 reports).

1 other recall cover devices cleared under the same FDA submission (K041115, K051989); 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 94 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50918239 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT PELVIS SURGERY WITH A GII QUICKANCHOR ORTHOCORD, THE NEEDLE FRACTURED WHILE ATTEMPTING TO PASS THE NEEDLE THROUGH THE PELVIC ISCHIUM BONE. RETRIEVAL OF THE FRACTURED NEEDLE WAS REQUIRED APPROXIMATELY 45 ADDITIONAL MINUTES OF OPERATING TIME, INCLUDING THE USE OF INTRAOPERATIVE X RAY IMAGING. NO PATIENT CONSEQUENCE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971125 ↗
• MalfunctionMar 11, 2026Packaging Problem

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE HAD A NON-CONFORMITY BETWEEN THE OUTER LABELING AND THE DEVICE CONTAINED IN THE BOX. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575008 ↗
• MalfunctionJan 21, 2026Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PATELLA TENDON REPAIR SURGICAL PROCEDURE THE GII QA+ O/C CP-2 DEVICE THE GII ANCHOR PULL OUT PROBLEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135678 ↗
• MalfunctionMay 28, 2025Unintended Movement; Unintended Movement

  (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY IT WAS OBSERVED THAT (2) GII QA+ O/C CP-2 DEVICES HAD LOOSE THREADS AND (1) GII QA+ O/C CP-2 DEVICE THREAD WAS BROKEN WITHOUT EXCESSIVE PULL. ACCORDING TO THE REPORTER, TWO ADDITIONAL IMPLANTS WERE THEN USED AND THERE WAS AN INCREASED RISK OF BONE FRACTURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096919 ↗
• MalfunctionMay 28, 2025Break; Break

  REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY IT WAS OBSERVED THAT (2) GII QA+ O/C CP-2 DEVICES HAD LOOSE THREADS AND (1) GII QA+ O/C CP-2 DEVICE THREAD WAS BROKEN WITHOUT EXCESSIVE PULL. ACCORDING TO THE REPORTER, TWO ADDITIONAL IMPLANTS WERE THEN USED AND THERE WAS AN INCREASED RISK OF BONE FRACTURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096874 ↗
• MalfunctionMay 28, 2025Unintended Movement; Unintended Movement

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY IT WAS OBSERVED THAT (2) GII QA+ O/C CP-2 DEVICES HAD LOOSE THREADS AND (1) GII QA+ O/C CP-2 DEVICE THREAD WAS BROKEN WITHOUT EXCESSIVE PULL. ACCORDING TO THE REPORTER, TWO ADDITIONAL IMPLANTS WERE THEN USED AND THERE WAS AN INCREASED RISK OF BONE FRACTURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096849 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE GII QUICK ANCHOR SUTURE ANCHOR DEVICE WAS IMPLANTED DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE NEEDLES PULLED OFF AND REMAINED IN THE ORIGINAL PACKAGING. IT WAS UNKNOWN IF THE EVENT OCCURRED DURING THE SURGICAL PROCEDURE. 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 21989822 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE GII QUICKANCHOR ORTHOCORD SUTURE DEVICE WAS USED ON THE PROXIMAL POLE OF THE PATELLA FOR REINSERTION OF THE QUADRICEPS TENDON. AFTER IMPACTION OF THE ANCHOR, THERE WAS GOOD HOLD, TENDON SUTURE WITH ONE OF THE STRANDS, BUT WHEN TIGHTENING AT THE ANCHOR THERE WAS BREAKAGE OF THE THREAD DURING TIGHTENING BY HAND. THE ANCHOR DEVICE WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576419 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURES FROM THE GII QUICKANCHOR ORTHOCORD DEVICE SUTURE ANCHOR RELEASED DIRECTLY FROM THE ANCHOR ITSELF. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890438 ↗
• MalfunctionSep 24, 2024Break; Crack; Break; Crack

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT SOME DAYS AFTER AN INITIAL BICEPS REHABILITATION PROCEDURE, BREAKAGE AND STRONG FRAYING OF TWO GII QA+ O/C CP-2 DEVICES WERE SEEN ON IMAGING, WHICH RESULTED IN A REOPERATION. THE INITIAL PROCEDURE HAS BEEN CAPTURED UNDER (B)(4) /IP-02166923 AND (B)(4)/IP-02166924. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20294972 ↗
• MalfunctionSep 24, 2024Break; Crack; Break; Crack

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE FOR BICEPS REHABILITATION, TWO GII QA+ O/C CP-2 DEVICES WERE USED FOR THE REINSERTION OF THE BICIPITAL TENDON. ACCORDING TO THE REPORT, STRONG FRAYING AND RUPTURE OF THE WIRES; AND BREAKING OF THE ANCHORS ON THE TWO DEVICES WERE SEEN ON THE IMAGES FOUR DAYS AFTER THE PROCEDURE WHICH LED TO A REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20294946 ↗
• MalfunctionSep 23, 2024Break; Crack; Break; Crack

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE FOR BICEPS REHABILITATION, IT WAS OBSERVED THAT TWO GII QA+ O/C CP-2 DEVICES BROKE WITHOUT APPLYING AN EXCESSIVE TRACTION. ANOTHER TWO LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20283278 ↗
• MalfunctionSep 23, 2024Break; Crack; Break; Crack

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE FOR BICEPS REHABILITATION, IT WAS OBSERVED THAT TWO GII QA+ O/C CP-2 DEVICES BROKE WITHOUT APPLYING AN EXCESSIVE TRACTION. ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS IMPLANTED AND THE STRANDS PULLED, IT WAS NOTICED THAT THE STRAND WAS "FRAYED" AND BROKE. ANOTHER TWO LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT SOME DAYS AFTER THE INITIAL PROCEDURE, BREAKAGE OF TWO GII QA+ O/C CP-2 DEVICES WERE SEEN ON IMAGING, WHICH RESULTED IN A REOPERATION. THE REOPERATION HAS BEEN CAPTURED UNDER (B)(4). THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282473 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A LATERAL COLLATERAL LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QA+ O/C CP-2 DEVICE BROKE OFF WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192649 ↗
• MalfunctionMar 15, 2024Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN NEW ZEALAND THAT DURING A TENDON REPAIR SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THREE GII QUICKANCHOR PLUS ORTHOCORD CP-2 DEVICES BROKE, "SUTURE PULL THROUGH". ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED. THERE WAS AN UNSPECIFIED DELAY IN THE SURGERY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910905 ↗
• MalfunctionMar 15, 2024Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN NEW ZEALAND THAT DURING A TENDON REPAIR SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THREE GII QUICKANCHOR PLUS ORTHOCORD CP-2 DEVICES BROKE, "SUTURE PULL THROUGH". ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED. THERE WAS AN UNSPECIFIED DELAY IN THE SURGERY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910904 ↗
• MalfunctionMar 15, 2024Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN NEW ZEALAND THAT DURING A TENDON REPAIR SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THREE GII QUICKANCHOR PLUS ORTHOCORD CP-2 DEVICES BROKE, "SUTURE PULL THROUGH". ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED. THERE WAS AN UNSPECIFIED DELAY IN THE SURGERY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910902 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 1 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777682 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 2 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR DEVICE REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777676 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR DEVICE REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777668 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 4 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR DEVICE REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777651 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 6 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR DEVICE REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777634 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A LATERAL COLLATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT WHEN TIGHTENED THE GII QUICKANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE, IT BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18468449 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN OPEN ELBOW SURGERY ON (B)(6) 2023, IT WAS OBSERVED THAT THE GII QA+ W #2 ORTHOCORD BROKE OFF THE ANCHOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17721296 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041115, K051989. One submission often covers many models, so check the product and lot details in each record.

• Z-1626-2013 · May 3, 2013 · Terminated
  GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery