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STRATAFIX SXPP1B201Recalls & reported problems

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

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Aug 28, 2019Terminated

    The product do not meet certain internal testing specifications.

    Z-1334-2020 · Root cause: Under Investigation by firm · FDA record ↗

Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices

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