LUPINE 210704Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705001033), received between Jan 2, 2025 and Jan 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

17 other recalls cover devices cleared under the same FDA submission (K040827, 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 16, 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.

• MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR A ROTATOR CUFF TEAR IT WAS OBSERVED THAT THE LUPINE PANALOK LOOP ARTH #2ETH DEVICE COULD NOT BE DEPLOYED WHEN INSERTING THE ANCHOR. IT WAS REPORTED THAT THE DEVICE WAS USED FOR THE LATERAL SIDE. TWO ADDITIONAL LUPINE PANALOK LOOP ARTH #2ETH DEVICES WERE USED AND THE SAME PROBLEM OCCURRED. ANOTHER ANCHOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060863 ↗
• MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR A ROTATOR CUFF TEAR IT WAS OBSERVED THAT THE LUPINE PANALOK LOOP ARTH #2ETH DEVICE COULD NOT BE DEPLOYED WHEN INSERTING THE ANCHOR. IT WAS REPORTED THAT THE DEVICE WAS USED FOR THE LATERAL SIDE. TWO ADDITIONAL LUPINE PANALOK LOOP ARTH #2ETH DEVICES WERE USED AND THE SAME PROBLEM OCCURRED. ANOTHER ANCHOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060804 ↗
• MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR A ROTATOR CUFF TEAR IT WAS OBSERVED THAT THE LUPINE PANALOK LOOP ARTH #2ETH DEVICE COULD NOT BE DEPLOYED WHEN INSERTING THE ANCHOR. IT WAS REPORTED THAT THE DEVICE WAS USED FOR THE LATERAL SIDE. TWO ADDITIONAL LUPINE PANALOK LOOP ARTH #2ETH DEVICES WERE USED AND THE SAME PROBLEM OCCURRED. ANOTHER ANCHOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 3 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060779 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827, K150209. 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-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-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-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-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-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.
• 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-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-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-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-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-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-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.

…and 2 more.