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LUPINE ORTHOCORD 210711Recalls & reported problems

Medos International Sàrl · LUPINE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) braided composite suture, violet 36 Inches (91cm). Size 2 (5 metric) eyelet loop. · Class 2 · Implant

All models of LUPINE ORTHOCORD (2)

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

Quick summary

This Lupine bone anchor with Orthocord suture is used to secure soft tissue to bone, mainly in shoulder and Bankart repair surgery. The 52 reports mostly describe the anchor or suture breaking during surgery, sometimes leaving small fragments in the patient or requiring another device to finish the operation, plus anchors found bent or damaged in the package before use. Reports mention 3 injuries and no deaths, and 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
52
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10886705001095), received between Jul 20, 2018 and Mar 19, 2025 — classified as 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (31 reports).

21 other recalls cover devices cleared under the same FDA submission (K040827, K070925, 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break31
  • Material Deformation15
  • Device Damaged Prior to Use10
  • Adverse Event Without Identified Device or Use Problem2
  • Detachment of Device or Device Component2
  • Deformation Due to Compressive Stress1
  • Device Contamination with Body Fluid1
  • Entrapment of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions33
  • No Consequences Or Impact To Patient15
  • Not Applicable2
  • Unspecified Tissue Injury2
  • Injury1
  • Unspecified Infection1

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE LUPINE BR W/ORTHCRD DEVICE, AFTER ANCHOR IMPLANTATION, DURING IMPLANT SHAFT WITHDRAWAL, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. 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 21641194 ↗
  • MalfunctionNov 8, 2024Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LUPINE BR W/ORTHCRD ANCHOR WAS BROKEN OFF. 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 20639485 ↗
  • MalfunctionOct 21, 2024Break; Break

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE LUPINE BR W/ORTHCRD DEVICE SUTURE WAS BROKEN. 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 20499216 ↗
  • MalfunctionApr 15, 2024Material Deformation; Material Deformation

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THAT ON OPENING THE PACK THE LUPINE BR W/ORTHCRD DEVICE ANCHOR WAS OBSERVED BENT FROM THE TIP. ACCORDING TO THE REPORTER, FOUR LUPINE BR ANCHORS WERE OPENED AND ONE OF THEM WAS BENT FROM THE TIP. IT WAS REPORTED THAT THREE LUPINE BR ANCHORS WERE DEPLOYED IN THE SURGERY HOWEVER ANOTHER ONE ANCHOR WAS BENT BEYOND USE. 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 19103922 ↗
  • MalfunctionMar 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE LUPINE BR W/ORTHCRD DEVICE THE SUTURE DETACHED FROM THE ANCHOR. 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 18887156 ↗
  • MalfunctionNov 29, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 WHILE TRYING TO INSERT THE ANCHOR OF THE LUPINE BR W/ORTHCRD DEVICE IT WAS NOTED THAT IT BROKEN IN THE MIDDLE OF THE ANCHOR BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18233802 ↗
  • MalfunctionMay 22, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, A LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE ORTHOCORD SUTURE AND THE SUTURE LOOP CAME OUT OF THE PATIENT WHILE THE ANCHOR STAYED IN THE BONE. IT WAS REPORTED THAT IT SEEMED THAT A SMALL PART OF THE ANCHOR WAS BROKEN WHERE THE SUTURE LOOP WENT THROUGH. IT WAS REPORTED THAT THE EVENT OCCURRED DURING A MINI-OPEN SUBPECTORAL LBS-TENODESIS. IT WAS REPORTED THAT THE BROKEN ANCHOR REMAINED IN THE PATIENT, AND THAT THERE WAS NO ATTEMPT MADE TO REMOVE IT. IT WAS UNKNOWN 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 16978128 ↗
  • MalfunctionJan 10, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE 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. THIS COMPLAINT INVOLVES X (X) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16130671 ↗
  • MalfunctionDec 20, 2022Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SUTURE BROKE WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16017100 ↗
  • MalfunctionDec 20, 2022Material Deformation; Material Deformation

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS DEFORMED UPON OPENING ITS PACKAGE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SUTURE BROKE WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16017098 ↗
  • MalfunctionDec 9, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN (B)(6) THAT DURING A BANKART REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT AT THE TIP UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS BENT. 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 15949668 ↗
  • MalfunctionNov 16, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT AT THE TIP UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BENT AT THE TIP. 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 15807501 ↗
  • MalfunctionNov 4, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

    THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022 , IT WAS OBSERVED THAT TWO LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICES WERE BENT UPON OPENING THEIR PACKAGES AND BROKE DURING USE. 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 15725695 ↗
  • MalfunctionNov 3, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

    THIS IS REPORT 1 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022 , IT WAS OBSERVED THAT TWO LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICES WERE BENT UPON OPENING THEIR PACKAGES AND BROKE DURING USE. 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 15722314 ↗
  • MalfunctionOct 31, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS BENT. 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 15703229 ↗
  • MalfunctionOct 24, 2022Material Deformation; Material Deformation

    THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FRONT OF THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT WHEN IT WAS OPENED. 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 15658335 ↗
  • MalfunctionOct 24, 2022Material Deformation; Material Deformation

    THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FRONT OF THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT WHEN IT WAS OPENED. 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 15658228 ↗
  • MalfunctionOct 24, 2022Material Deformation; Material Deformation

    THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FRONT OF THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT WHEN IT WAS OPENED. 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 15658219 ↗
  • MalfunctionOct 24, 2022Material Deformation; Material Deformation

    THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FRONT OF THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT WHEN IT WAS OPENED. 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 15658158 ↗
  • MalfunctionOct 24, 2022Material Deformation; Material Deformation

    THIS IS REPORT 2 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FRONT OF THE ANCHOR ON THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE WAS BENT WHEN IT WAS OPENED. 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 15658157 ↗
  • MalfunctionAug 11, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THREE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICES WERE BENT AT THE TIP AND BEYOND USE. 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 15212450 ↗
  • MalfunctionAug 11, 2022Break; Device Damaged Prior to Use; Device Contamination with Body Fluid; Material Deformation; Break; Device Damaged Prior to Use; Device Contamination with Body Fluid; Material Deformation

    THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THREE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICES WERE BENT AT THE TIP AND BEYOND USE. 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 15212395 ↗
  • MalfunctionAug 11, 2022Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THREE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICES WERE BENT AT THE TIP AND BEYOND USE. 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 15212393 ↗
  • MalfunctionAug 2, 2022Break; Break

    IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE FRACTURED UPON IMPLANTATION; AND A SMALL FRAGMENT WAS DISLODGED BUT WAS LATER RETRIEVED AND REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15147319 ↗
  • MalfunctionJul 25, 2022Material Deformation; Material Deformation

    IT WAS REPORTED BY THE CUSTOMER IN INDIA THAT DURING A SHOULDER INSTABILITY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DEVICE GOT BENT. 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 15098531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827, K070925, K150209. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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-1166-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1162-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1163-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1171-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1164-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1165-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1169-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1168-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1170-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Z-1167-2012 · Jan 27, 2012 · Terminated
    Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

…and 6 more.

Other Suture, nonabsorbable, synthetic, polyester devices

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Sources and updates

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