HEALIX ADVANCERecalls & reported problems across all models
Depuy Mitek, LLC · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 873
- Deaths reported
- 0
- Injuries reported
- 73
- Recalls
- 2
We found 6 models of HEALIX ADVANCE by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 873 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Sep 30, 2026 — classified as 73 injuries, 800 malfunctions.
The most frequently reported specific device problem is “Break” (690 reports).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
HEALIX ADVANCE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 4, 2019Class IITerminated
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
Z-0666-2020 · Root cause: Employee error · Recall details · FDA record ↗
- Nov 4, 2019Class IITerminated
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
Z-0665-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported HEALIX ADVANCE problems
Device problems
- Break690
- Crack52
- Migration36
- Adverse Event Without Identified Device or Use Problem27
- Migration or Expulsion of Device27
- Material Deformation15
- Fracture9
- Detachment of Device or Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions508
- No Consequences Or Impact To Patient263
- Not Applicable45
- Injury32
- Unspecified Tissue Injury17
- Unspecified Infection15
- No Code Available11
- No Known Impact Or Consequence To Patient10
HEALIX ADVANCE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HEALIX ADVANCE 222330FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE 222331FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
- HEALIX ADVANCE 222333FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE29 reports
- HEALIX ADVANCE 222334FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE25 reports
- HEALIX ADVANCE 222332FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE13 reports
- HEALIX ADVANCE 222335FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
Recent HEALIX ADVANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951531 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951525 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949212 ↗MalfunctionSep 29, 2026Material Deformation; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933380 ↗MalfunctionSep 29, 2026Material Deformation; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933377 ↗MalfunctionSep 29, 2026Break
This is report 1 of 5 for (b)(4).It was reported that during an Anterior Cruciate Ligament Reconstruction surgery, four anchors on the 4.75 HEALIX ADVANCE KNTLSS BR devices and one screw on the INTRAFX ADVBR SCW7X23 W/SMSHTH 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 50932950 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923286 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918941 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 3 of 3 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880667 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880666 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880665 ↗MalfunctionSep 23, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 4.75 HEALIX ADVANCE KNTLSS BR anchor device broke. All broken parts were removed. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed. This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871570 ↗MalfunctionSep 23, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 4.75 HEALIX ADVANCE KNTLSS BR anchor device broke. All broken parts were removed. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the procedure. There was no delay in the procedure reported. There was no adverse patient consequences reported. All available information has been disclosed. This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871563 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another three HEALIX ADVANCE ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 4 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867659 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828686 ↗
Other Depuy Mitek, LLC products
- VAPR30 models · 1,986 reports
- VAPR COOLPULSE2 models · 779 reports
- FMS9 models · 434 reports
- BIOKNOTLESS PANACRYL ETHIBOND3 models · 35 reports · 2 recalls
- LUPINE ORTHOCORD4 models · 112 reports
- QUICKANCHOR ETHIBOND TAPERCUT2 models · 104 reports
- INTRAFIX14 models · 91 reports
- MILAGRO10 models · 88 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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