Henry Schein 900-7466Recalls & reported problems
Henry Schein, Inc. · HS C3 4-0 BK MN NYL 18"/45CM · Class 2 · Implant
Data updated Oct 16, 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 00304040000106), received between May 4, 2026 and May 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionMay 4, 2026Material Fragmentation
IT WAS REPORTED ON (B)(6) 2026 THAT DURING USE A PART OF THE SUTURE NEEDLE BROKE OFF INTO THE PATIENT'S SKIN. AN X-RAY WAS DONE TO LOCATE THE NEEDLE PIECE AND IT WAS SUCCESSFULLY REMOVED. NO ADDITIONAL INJURIES OR MEDICAL INTERVENTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071367 ↗
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- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
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- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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