HEALIX ADVANCE PEEK ANCHOR w/DYNACORD 222032Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE PEEK ANCHOR w/DYNACORD PEEK Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric) DYNACORD Suture, 36" (91cm) 5.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705029495), received between Dec 7, 2020 and Dec 7, 2020 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: PREVIOUS ROTATOR CUFF REPAIR. PROVISIONAL DIAGNOSIS NOW OF INFECTION. ALL MITEK ANCHORS IMPLANTED PREVIOUSLY AT CUFF REPAIR REMOVED. SURGEON PERFORMED THE PRIMARY SURGERY - HE BELIEVED THERE WAS ONLY 4 X MITEK ANCHORS IMPLANTED, BUT IMPLANT STICKERS IN PATIENT'S CHART FROM PRIMARY SURGERY INDICATE 6 X ANCHORS. REMOVED 4 X ANCHORS - NO OTHER ANCHORS FOUND. MULTIPLE SPECIMENS TAKEN. REMOVED ANCHORS ALSO SENT OFF FOR MICROSCOPY / INFECTION. DEVICES ARE RETAINED BY CUSTOMER.
Patient problems: Unspecified Infection
MAUDE report 10962932 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: PREVIOUS ROTATOR CUFF REPAIR. PROVISIONAL DIAGNOSIS NOW OF INFECTION. ALL MITEK ANCHORS IMPLANTED PREVIOUSLY AT CUFF REPAIR REMOVED. SURGEON PERFORMED THE PRIMARY SURGERY - HE BELIEVED THERE WAS ONLY 4 X MITEK ANCHORS IMPLANTED, BUT IMPLANT STICKERS IN PATIENT'S CHART FROM PRIMARY SURGERY INDICATE 6 X ANCHORS. REMOVED 4 X ANCHORS - NO OTHER ANCHORS FOUND. MULTIPLE SPECIMENS TAKEN. REMOVED ANCHORS ALSO SENT OFF FOR MICROSCOPY / INFECTION. DEVICES ARE RETAINED BY CUSTOMER.
Patient problems: Unspecified Infection
MAUDE report 10962855 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page