HEALIX TRANSTEND ORTHOCORD 222260Recalls & reported problems
Medos International Sàrl · HEALIX TRANSTEND Ti Anchor with ORTHOCORD Titanium Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 2.9mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705008063), received between Jun 15, 2018 and Jun 27, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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
- Activation, Positioning or Separation Problem1
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING A SHOULDER ARTHROSCOPY SURGERY (BANKART REPAIR), THE ANCHOR KEPT ATTACHED TO ITS INSERTOR. IT WAS IMPOSSIBLE TO DELIVER IT AFTER THE SCREWING. 1 PART INVOLVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: NO PATIENT IMPACT AND THERE WAS NO DELAY IN PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7642115 ↗MalfunctionJun 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE NEEDLE PULLED OUT. NO MORE DETAILS. THEY USED ANOTHER LIKE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7605434 ↗
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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.
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