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LUPINE ORTHOCORD 210709Recalls & reported problems

Depuy Mitek, LLC · LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composite sutures, Violet and Blue 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop. · Class 2 · Implant

All models of LUPINE ORTHOCORD (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This DePuy Mitek Lupine Loop Plus anchor with Orthocord sutures is a bone-fixing staple used in shoulder, knee and other orthopedic surgery. Its 56 reports mostly describe the anchor breaking during surgery, along with material deforming or twisting, and a few cases of the anchor pulling out or parts detaching. Reports mention no deaths and no injuries; in most cases broken pieces were removed and surgery continued with a spare device. 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
56
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886705001071), received between Aug 24, 2018 and Sep 11, 2025 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Break” (33 reports).

7 other recalls cover devices cleared under the same FDA submission (K062170); 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

Nov 2023: 3 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 3 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break33
  • Material Deformation17
  • Material Twisted/Bent12
  • Device Damaged Prior to Use4
  • Detachment of Device or Device Component3
  • Migration3
  • Crack1
  • Deformation Due to Compressive Stress1

Patient problems

  • No Clinical Signs, Symptoms or Conditions45
  • No Consequences Or Impact To Patient7
  • No Known Impact Or Consequence To Patient3
  • Not Applicable3
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 11, 2025Break; Break

    IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 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 23028250 ↗
  • MalfunctionAug 14, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE; IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 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 22805959 ↗
  • MalfunctionJul 10, 2025Break; Break

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN, REMOVED ALL THE BROKEN PARTS. 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 22467287 ↗
  • MalfunctionJan 6, 2025Break; Break

    REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE LUPINE LOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21079946 ↗
  • MalfunctionJan 6, 2025Break; Break

    REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21079944 ↗
  • MalfunctionJan 2, 2025Break; Break

    IT WAS REPORTED FROM THE HEALTH AUTHORITY IN CHINA THAT DURING A RIGHT PATELLAR LIGAMENT PLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21059154 ↗
  • MalfunctionSep 18, 2024Break; Break

    IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL PARTS WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20250941 ↗
  • MalfunctionSep 4, 2024Migration; Migration

    IT WAS REPORTED FROM CHINA THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE PULLED OUT. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20135714 ↗
  • MalfunctionJan 9, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18476042 ↗
  • MalfunctionNov 30, 2023Break; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Break; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER AND ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, THE PACKAGING OF THE LUPINE LOOP PLUS DUAL SUTURE (DS) ANCHOR W/ORTHOCORD PLA ABSORBABLE ANCHOR DEVICE WAS OPENED BUT NOT USED, AND IT WAS NOTICED TO BE DEFORMED. SEVEN REPLACEMENTS WERE ATTEMPTED TO PROCEED WITH THE SURGERY; HOWEVER, THE SAME ISSUE RECURRED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WAS FRACTURED. 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 18236158 ↗
  • MalfunctionNov 14, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON 10/10/2023, IT WAS OBSERVED THAT THE END OF THE SHAFT ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS BROKEN AFTER INSERTION AND COULD NOT BE REMOVED; AND THEREFORE, THE ANCHOR REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 18130153 ↗
  • MalfunctionNov 14, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE WAS BROKEN OFF THEN, ALL THE BROKEN PARTS WERE REMOVED. 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 18129896 ↗
  • MalfunctionOct 17, 2023Migration; Migration

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE TWO (X2) LUPINELOOPPLUS ANCHOR W/OC DS DEVICES ANCHOR BROKE AND PULLED OUT. THE ANCHOR WAS BROKEN OFF AND ALL BROKEN PARTS WERE REMOVED. ANOTHER ANCHOR WAS USED AND THAT WAS PULLED OUT. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17950808 ↗
  • MalfunctionOct 17, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE TWO (X2) LUPINELOOPPLUS ANCHOR W/OC DS DEVICES ANCHOR BROKE AND PULLED OUT. THE ANCHOR WAS BROKEN OFF AND ALL BROKEN PARTS WERE REMOVED. ANOTHER ANCHOR WAS USED AND THAT WAS PULLED OUT. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17950034 ↗
  • MalfunctionSep 12, 2023Device Damaged Prior to Use; Detachment of Device or Device Component; Material Deformation; Device Damaged Prior to Use; Detachment of Device or Device Component; Material Deformation

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS NOT RECEIVED ALONG WITH THE DEVICE; BUT IT WAS OBSERVED THAT THE TIP WAS DEFORMED AND THE SUTURE WAS NOT IN THE SHAFT. 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 17730908 ↗
  • MalfunctionSep 7, 2023Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A REPAIR OF INTERNAL AND EXTERNAL COLLATERAL LIGAMENT INJURIES OF THE KNEE JOINT PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE; AND THEREFORE, WAS NOT USED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS WAS NOT ASSEMBLED IN THE SHAFT OF THE DEVICE. 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 17703285 ↗
  • MalfunctionAug 9, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 17492482 ↗
  • MalfunctionJun 27, 2023Migration; Migration

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN TRAUMA PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP PLUS ANCHOR W/ORTHOCORD DS DEVICE PULLED OUT AFTER INSERTION. 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 17210774 ↗
  • MalfunctionDec 15, 2021Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT BEFORE TO A SHOULDER INSTABILITY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF A PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE ANCHOR WAS DEFORMED, AND STILL ATTACHED TO THE INSERTER VIA THE TENSIONED SUTURE. 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 13011765 ↗
  • MalfunctionDec 3, 2021Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS DEFORMED AND BROKEN. 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 12923007 ↗
  • MalfunctionDec 2, 2021Break; Break

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT BOTH THE ANCHOR AND SUTURE ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WERE BROKEN. 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 12920205 ↗
  • MalfunctionDec 2, 2021Break; Break

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. 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 12919971 ↗
  • MalfunctionDec 2, 2021Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS DEFORMED AND BROKEN. 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 12919456 ↗
  • MalfunctionDec 2, 2021Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE WAS DEFORMED AND BROKEN. 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 12919430 ↗
  • MalfunctionNov 17, 2021Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

    IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR ON THE LUPINELOOPPLUS ANCHOR W/OC DS DEVICE BROKE. THERE WERE NO FRAGMENTS GENERATED. 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 12831376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062170. One submission often covers many models, so check the product and lot details in each record.

  • 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
  • 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-0316-2012 · Oct 31, 2011 · Terminated
    DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate pos
  • Z-0315-2012 · Oct 31, 2011 · Terminated
    DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate posto

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Sources and updates

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