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Swish™ Basic Surgical Tray SPBSTRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 2

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 10841307117582), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

  • Device Markings/Labelling Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 2, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

    (B)(4) DISTRIBUTOR FOUND DURING INCOMING INSPECTION, A LACK OF GROOVING'S AND LASER MARKINGS. DISTRIBUTOR RECEIVED THE CORRECT PART, HOWEVER THEY RECEIVED THE PREVIOUS REVISION OF THIS DRILL WHICH IS NOW MARKETED WITH THE NEW GROOVING'S AND LASER MARKINGS. DISTRIBUTOR REQUESTED REPLACEMENTS WITH THE NEWEST REVISIONS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7481945 ↗

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