STRATAFIX SXMP1B105Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
Data updated Oct 13, 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 10705031236653), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fluid Discharge1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELBOW SURGERY FOR AN OLECRANON FRACTURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SURGEON NOTICED ON (B)(6) 2023 THAT THE WOUND HAD SOME FLUIDS COMING OUT. HE ASSUMES THAT IT MIGHT BE A REACTION TO THE BARBED SUTURE OR THE METAL IMPLANTS HE USED. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2023 TO REMOVE THE IMPLANTS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Fluid Discharge; Unspecified Infection
MAUDE report 18135839 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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