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STRATAFIX SXPP1B204Recalls & reported problems

Ethicon, LLC · Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant

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 10705031236004), received between Apr 30, 2018 and Apr 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure To Adhere Or Bond1

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.

  • MalfunctionApr 30, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2018 AND BARBED SUTURE WAS USED TO CLOSE THE CAPSULE. THE SUTURE BARBS DID NOT HOLD THE TISSUE, SO WERE PULLING OUT. THE PROCEDURE WAS COMPLETED WITH A COMPETITIVE SUTURE WITH NO PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7474297 ↗

Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices

All SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.