Myo/Wire II 040-355Recalls & reported problems
A & E Medical Corporation · SS Suture, 6 per sleeve · 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 10841291101635), received between Oct 7, 2024 and Oct 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
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
- Delivered as Unsterile Product2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT IS REPORTED THAT THE WIRE PACKAGING'S STERILITY WAS COMPROMISED DUE TO OPEN PACKAGING. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20381902 ↗MalfunctionOct 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT IS REPORTED THAT THE WIRE PACKAGING'S STERILITY WAS COMPROMISED DUE TO OPEN PACKAGING. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20381897 ↗
Other Suture, Nonabsorbable devices
- Myo/Wire II 046-367A & E Medical Corporation · Suture, Nonabsorbable4 reports
- Myo/Wire II 040-308A & E Medical Corporation · Suture, Nonabsorbable2 reports
- Myo/Wire II 046-093A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 040-397A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-181A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-062A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 040-365A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-267A & E Medical Corporation · Suture, Nonabsorbable1 report
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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