ULTRAFIX MICROMITE STITCHPAK 10301Recalls & reported problems
Conmed Corporation · ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR WITH ATTACHED 2/0 (.35 MM) POLYESTER SUTURE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854040338), received between Dec 4, 2023 and Dec 4, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE 10301, ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR DEVICE WAS BEING USED DURING A LEFT THUMB ULNAR COLLATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED POST OPERATIVELY ¿PATIENT HAD A UCL ON HER THUMB IN (B)(6) AND SHE WAS QUITE SATISFIED WITH HER RESULTS. HOWEVER, 8 WEEKS AFTER THE SURGERY, SHE STARTED GETTING BUMPS SIMILAR TO PIMPLES AND THAT THEY TURNED INTO POX-LIKE LESIONS THAT SOON ERUPTED. SHE SAID THAT NOW 90% OF HER BODY IS COVERED WITH THESE POX-LIKE BUMPS AND OPEN SORE. THEY ARE CAUSING HER PAIN AND UNBEARABLE ITCHING. SHE HAS GONE TO THE DOCTOR AND THE SURGERY CENTER TO TRY TO FIND OUT WHAT THE ISSUE IS, BUT DOESN¿T FEEL LIKE THEY ARE TAKING HER SERIOUSLY. DURING HER PRE-SURGERY APPOINTMENT, SHE SAID SHE MADE SURE THE DR KNEW OF HER AUTOIMMUNE ISSUES AND THAT SHE WAS ALSO ALLERGIC TO NICKEL. THE DR OFFICE (I BELIEVE) TOLD HER THAT THE ANCHOR USED WAS THE LINVATEC MIGHY MITE. SHE HAS BEEN TO THE ER BECAUSE THIS REACTION IS AFFECTING HER BREATHING¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿ SURGICAL SITE PREPPED WITH HIBICLENS AND ALCOHOL. THERE ARE NO CURRENT PLANS TO REMOVE THE IMPLANT FROM THE PATIENT. THE PATIE
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18257907 ↗
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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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