Sharpoint Plus B1627NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Plain Gut 4-0 1x18" PS-2 · Class 2 · Implant
Data updated Oct 16, 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 00848782030446), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
InjuryMay 23, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT THE SUTURE BROKE POST-OP AND THE PATIENT RETURNED TO BE RE-SUTURED. NO ADDITIONAL INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081707 ↗
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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