N/A 558CGRecalls & reported problems
C.P. Medical Corporation · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10790986001777), received between Jul 16, 2024 and May 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Integrity Problem2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, "SUTURE BREAKING EASILY AND BRITTLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053445 ↗MalfunctionJul 16, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
ACCORDING TO (B)(6),THERE WERE MULTIPLE SUTURE BREAKS DURING TOOTH EXTRACTION SURGERIES. THE CLINIC ALSO NOTICED THAT THE SUTURE APPEARED TO BE A DIFFERENT COLOR THAN NORMAL COMPARED TO PREVIOUS SUTURE LOTS RECEIVED. THE CLINIC REPORTS THAT THIS INCIDENT HAPPENED SEVERAL TIMES WITH MULTIPLE LOT NUMBERS FOR THE 558CG PRODUCT CODE, BUT THESE LOT NUMBERS WERE NOT REPORTED TO CP MEDICAL THE PROCEDURE DID NOT EXPERIENCE A DELAY GREATER THAN 30 MINUTES; HOWEVER, THIS WAS AN INCONVENIENCE FOR THE USER. NO PATIENTS WERE HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19750276 ↗MalfunctionJul 16, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
ACCORDING TO BRAD WELSH DENTISTRY,THERE WERE MULTIPLE SUTURE BREAKS DURING TOOTH EXTRACTION SURGERIES. THE CLINIC ALSO NOTICED THAT THE SUTURE APPEARED TO BE A DIFFERENT COLOR THAN NORMAL COMPARED TO PREVIOUS SUTURE LOTS RECEIVED. THE CLINIC REPORTS THAT THIS INCIDENT HAPPENED SEVERAL TIMES WITH MULTIPLE LOT NUMBERS FOR THE 558CG PRODUCT CODE, BUT THESE LOT NUMBERS WERE NOT REPORTED TO CP MEDICAL THE PROCEDURE DID NOT EXPERIENCE A DELAY GREATER THAN 30 MINUTES; HOWEVER, THIS WAS AN INCONVENIENCE FOR THE USER. NO PATIENTS WERE HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749693 ↗
Other Suture, Absorbable, Natural devices
- Chromic Gut GG-122Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall12 reports
- Chromic Gut G-1780KCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall8 reports
- Chromic Gut UG-202Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall7 reports
- Chromic Gut UG-203Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Plain Gut SG-5686Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut SG-5687GCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-123Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-121Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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