ORTHOCORD 223127Recalls & reported problems
Medos International Sàrl · ORTHOCORD Violet Braided Composite Suture C-1 13 mm 3/8c, Taper Point N=1 Meets U.S.P. and E.P. except for diameter 4-0 (1.5 metric), 18 Inches (45 cm) · Class 2 · Implant
All models of ORTHOCORD (14)
Data updated Oct 18, 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 10886705022946), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2018Break; Break
IT WAS REPORTED BY THE CUSTOMER VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE CUSTOMER'S ORTHOCORD SIZE #4 VIOLET BROKE. THE CUSTOMER WAS UNABLE TO PROVIDE THE QUANTITY OF SUTURES THAT BROKE, AS THE USED DEVICES WERE DISCARDED. THE CUSTOMER STATED THAT THE PRODUCTS CAME FROM THE SAME LOT NUMBER, AND REQUESTED THAT THE PRODUCTS ON THE SHELF BE RETURNED. THE CUSTOMER WAS NOT PRESENT AND UNABLE TO PROVIDE ANY INFORMATION. THE UNUSED DEVICES ARE BEING RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7897561 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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