GII QUICKANCHOR ETHIBOND 212034Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10886705001828), received between Jun 21, 2018 and Sep 25, 2026 — classified as 13 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Break” (57 reports).

1 other recall cover devices cleared under the same FDA submission (K041115, K902751, K915889); 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 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that during an unknown surgery, the GII QUICKANCHOR ETHIBOND device threads broke in GII anchors. 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 50895782 ↗
• MalfunctionSep 25, 2026Break

  It was reported that during an unknown surgery, the GII QUICKANCHOR ETHIBOND device threads broke in GII anchors. 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 50895778 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GII QA+ #2 ETH CP-2 DEVICE STRAND BROKE WHEN KNOTTING. 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 23490379 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GII QA+ #2 ETH CP-2 DEVICE STRAND BROKE WHEN KNOTTING. 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 23490237 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR A BILATERAL TENOTOMY FOR CLUBFOOT EQUINOVARUS IT WAS OBSERVED THAT WHEN USING THE GII QA+ #2 ETH CP-2 QUICKANCHOR DEVICE IT WAS OBSERVED THAT THE SUTURE THREADS HAD PULLED OFF FROM THE ANCHOR. 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 22054780 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE 2X GII QA DEVICE ANCHORS WERE LAID, THE TENDON SNEAKED, WHEN TIGHTENING THE KNOTS BY HAND AND THE WIRES BROKE. IT WAS NOT POSSIBLE TO REMOVE THE ANCHORS WITHOUT WEAKENING THE BONE. IT WAS VERY COMPLICATED TO FIND PLACE TO IMPLANT TWO MORE ANCHORS. THE PROCEDURE WAS EXTENDED. THE TWO ANCHORS WERE IMPOSSIBLE TO EXTRACT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472753 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE 2X GII QA DEVICE ANCHORS WERE LAID, THE TENDON SNEAKED, WHEN TIGHTENING THE KNOTS BY HAND AND THE WIRES BROKE. IT WAS NOT POSSIBLE TO REMOVE THE ANCHORS WITHOUT WEAKENING THE BONE. IT WAS VERY COMPLICATED TO FIND PLACE TO IMPLANT TWO MORE ANCHORS. THE PROCEDURE WAS EXTENDED. THE TWO ANCHORS WERE IMPOSSIBLE TO EXTRACT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472751 ↗
• MalfunctionFeb 7, 2025Use of Device Problem; Detachment of Device or Device Component; Migration; Use of Device Problem; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING A TENDON TRANSFER PROCEDURE, IT WAS DISCOVERED THE THREAD DETACHED FROM THE ANCHOR ON THE GII QUICKANCHOR+#2 ETH CP-2 EA DEVICE. ADDITIONALLY, IT WAS NOTED THAT THE ANCHOR'S IMPLANTATION WAS INEFFECTIVE, AS IT FAILED TO FUNCTION PROPERLY. IT WAS REPORTED THAT THE DOUBLE ANCHOR IMPLANTATION WAS UNSUCCESSFUL FOR THE PATIENT, WITH THE SECOND DEVICE IMPLANTED DIFFERENTLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT 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 21335933 ↗
• MalfunctionDec 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE FOR TRANSFER OF ANTERIOR TIBIAL TENDON TO LATERAL CUNEIFORM, IT WAS OBSERVED THAT THE DEVICE BROKE SPONTANEOUSLY. THERE WAS PATIENT INVOLVEMENT. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20966553 ↗
• MalfunctionOct 25, 2024Migration; Migration

  IT WAS REPORTED FROM JAPAN THAT DURING AN ELBOW LIGAMENT REPAIR PROCEDURE FOR AN ELBOW LIGAMENT RUPTURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE GII QA+ #2 ETH CP-2 *EA DEVICE WAS PLACED IN THE BONE. HOWEVER, WHEN THE THREAD WAS PULLED TO TIE IT, THE ANCHOR CAME LOOSE. THE SURGEON CONCLUDED THAT THE PRODUCT WAS LIKELY FAULTY, NOTING THAT WHILE THE PATIENT'S BONE MIGHT HAVE BEEN WEAK, THE PRODUCT ITSELF COULD ALSO HAVE AN ISSUE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532492 ↗
• MalfunctionJul 22, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED, THAT WIRES ON TWO GII QA+ #2 ETH CP-2 DEVICES BROKE QUICKLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793091 ↗
• MalfunctionJul 22, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED, THAT WIRES ON TWO GII QA+ #2 ETH CP-2 DEVICES BROKE QUICKLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792908 ↗
• MalfunctionJun 21, 2024Break; Migration; Break; Migration

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT AFTER AN OSTEOSYNTHESIS FOR TIBIA SURGICAL PROCEDURE ON (B)(6) 2024 A POSTOPERATIVE X-RAY SHOWED THAT THE GII QA+ #2 ETH CP-2 *EA DEVICE ANCHOR CAME OFF FROM THE BONE. USUALLY, AFTER AN ANCHOR IS DRIVEN IN, A LID IS SLID OFF AND THE SUTURES ARE DISCONNECTED. ACCORDING TO THE SURGEON, THE LID WAS STIFF AND IT TOOK A LONG TIME TO SLIDE IT OFF, AND THE ANCHOR MAY HAVE LOOSENED WHILE BREAKING THE LID BECAUSE IT DID NOT COME OFF. THE X-RAY SHOWED THAT THERE WERE NO BROKEN PIECES IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY IN THIRTY MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583625 ↗
• MalfunctionJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QA+ #2 ETH CP-2 * DEVICE GOT DETACHED FROM THE ANCHOR DURING IMPLANTATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 19520988 ↗
• MalfunctionMay 1, 2024Crack; Migration; Crack; Migration

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SUTURES OF (X2) GII QA+ #2 ETH CP-2 DEVICES DID NOT HOLD, THEY CUT WHEN THE ANCHOR OF ONE WAS TESTED. THERE WAS A THIRTY MINUTE 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 19220957 ↗
• MalfunctionMay 1, 2024Crack; Migration; Crack; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SUTURES OF (X2) GII QA+ #2 ETH CP-2 DEVICES DID NOT HOLD, THEY CUT WHEN THE ANCHOR OF ONE WAS TESTED. THERE WAS A THIRTY MINUTE 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 19220952 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN THE UNITED KINGDOM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) GII QA+ #2 ETH CP-2 DEVICES WERE BEING USED WHEN BOTH DEVICES SNAPPED. IT WAS REPORTED THAT THIS OCCURRED WITH THE PATIENT ON THE TABLE, AFTER THE ANCHORING WAS DONE AND WHILST TYING THE SUTURE. THE SURGEON WAS UNABLE TO REMOVE THE ANCHORED SUTURE, IT WAS CHANGED AND REINFORCED WITH A LIKE DEVICE IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165347 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN THE UNITED KINGDOM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) GII QA+ #2 ETH CP-2 DEVICES WERE BEING USED WHEN BOTH DEVICES SNAPPED. IT WAS REPORTED THAT THIS OCCURRED WITH THE PATIENT ON THE TABLE, AFTER THE ANCHORING WAS DONE AND WHILST TYING THE SUTURE. THE SURGEON WAS UNABLE TO REMOVE THE ANCHORED SUTURE, IT WAS CHANGED AND REINFORCED WITH A LIKE DEVICE IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165326 ↗
• MalfunctionFeb 2, 2024Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SUTURE ON THE GII QA+ #2 ETH CP-2 DEVICE PULLED OUT UPON FIXATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632368 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING A SURGICAL PROCEDURE OF THE BICEPS AT THE ELBOW, PERFORMED ON (B)(6) 2023 REINSERTION OF TWO GII QUICKANCHOR ETHIBOND G2 ANCHORS IN THE BICIPITAL TUBEROSITY WITHOUT DIFFICULTY. REALIZATION OF THE KNOT BY HAND WITH THE THREAD OF THE FIRST ANCHOR, FROM THE FIRST "LOOP" THE THREAD BROKE. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325969 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING A SURGICAL PROCEDURE OF THE BICEPS AT THE ELBOW, PERFORMED ON (B)(6) 2023 REINSERTION OF TWO GII QUICKANCHOR ETHIBOND G2 ANCHORS IN THE BICIPITAL TUBEROSITY WITHOUT DIFFICULTY. REALIZATION OF THE KNOT BY HAND WITH THE THREAD OF THE FIRST ANCHOR, FROM THE FIRST "LOOP" THE THREAD BROKE. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325936 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED BONE RESECTION OF THE LOWER LIMB ON (B)(6) 2023 WHILE USING THE GII QA+ #2 ETH DEVICE THE ANCHOR PULLED OFF THE INSTALLATION DEVICE DURING PLACEMENT. ANOTHER LIKE 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 17938741 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GII® QUICKANCHOR® PLUS, SINGLE PACK DEVICE SNAPPED. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17844409 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY J&J EMPLOYEE THAT UNDER SYNTHES COMPLAINT (B)(4) USAGE OF MITEK DEVICES (GII® QUICKANCHOR® PLUS, SINGLE PACK) WAS IDENTIFIED. EVENT DESCRIPTION: "IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO METALOSIS. ULTAMET METAL LINER/HEAD. THE HIP JOINT WAS BLACK AND GREEN WITH METAL DEBRIS. ADDITIONAL INFORMATION EVENT IN THE DER REPORTED OSTEOLYSIS. PRODUCT ISSUES WAS SUSPECTED AND CONTRIBUTED TO THE EVENT. DOI: UNKNOWN: DOR: (B)(6) 2021: LEFT HIP".

  Patient problems: Foreign Body Reaction

  MAUDE report 17699373 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY J&J EMPLOYEE THAT UNDER SYNTHES COMPLAINT (B)(4) USAGE OF MITEK DEVICES (GII® QUICKANCHOR® PLUS, SINGLE PACK) WAS IDENTIFIED. EVENT DESCRIPTION: "IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO METALOSIS. ULTAMET METAL LINER/HEAD. THE HIP JOINT WAS BLACK AND GREEN WITH METAL DEBRIS. ADDITIONAL INFORMATION EVENT IN THE DER REPORTED OSTEOLYSIS. PRODUCT ISSUES WAS SUSPECTED AND CONTRIBUTED TO THE EVENT. DOI: UNKNOWN: DOR: (B)(6) 2021: LEFT HIP".

  Patient problems: Foreign Body Reaction

  MAUDE report 17699367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041115, K902751, K915889. 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