POLYPRO 8682PRecalls & reported problems
C.P. Medical Corporation · Class 2 · Implant
Data updated Oct 16, 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 10790986003559), received between Sep 27, 2019 and Sep 27, 2019 — classified as 2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2019Break
IT WAS REPORTED THAT SIZE 4/0 POLYPROPYLENE SUTURE BROKE DURING NORMAL PROCEDURE. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. THE ONLY KNOWN INFORMATION IS THE PRODUCT NUMBER. (8682P) EITHER LOT# 190425-56 OR LOT# 181227-54 IS ASSOCIATED WITH THE EVENT. TESTING AND INVESTIGATION WAS COMPLETED ON BOTH LOTS FOR DOCUMENTATION PURPOSES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9131345 ↗MalfunctionSep 27, 2019Break
IT WAS REPORTED THAT SIZE 4/0 POLYPROPYLENE SUTURE BROKE DURING NORMAL PROCEDURE. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. THE ONLY KNOWN INFORMATION IS THE PRODUCT NUMBER. (8682P) EITHER LOT# 190425-56 OR LOT# 181227-54 IS ASSOCIATED WITH THE EVENT. TESTING AND INVESTIGATION WAS COMPLETED ON BOTH LOTS FOR DOCUMENTATION PURPOSES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. AMENDMENT: TESTING AND INVESTIGATION WAS COMPLETED PER ISSUE LOT# 181227-54.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9131344 ↗
Other Suture, Nonabsorbable, Synthetic, Polypropylene devices
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- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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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