Hi-Fi HT7110Recalls & reported problems
Conmed Corporation · 2MM Hi-Fi® Tape Blue · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405005476), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K100006); 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
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Labelling, Instructions for Use or Training Problem
ACCORDING TO THE REPORTER, "PLEASE SEE BELOW FOR DETAILS OF NONCONFORMANCE IDENTIFIED AT INSPECTION. THIS NOTIFICATION IS STRICTLY FOR DOCUMENTATION PURPOSES. RMA FOR THE INDIVIDUAL BOX (QTY: 12) HAS BEEN RECEIVED. REST OF LOT WILL GO TO STOCK AND 1 UNIT WILL BE RETURNED. 1 BOX OF 12 RECEIVED WITH WRONG ARTWORK ON LABEL. LOT # 22100328."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019814 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100006. One submission often covers many models, so check the product and lot details in each record.
- Z-2762-2016 · Aug 5, 2016 · TerminatedPolypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, inc
- Z-2761-2016 · Aug 5, 2016 · TerminatedNylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For u
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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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