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GAMMA 3330-0400SRecalls & reported problems

Stryker GmbH · Long Nail Kit R2.0, Ti, LEFT · Class 2 · Implant

All models of GAMMA (249)

Data updated Oct 16, 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 07613153313809), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1
  • Impaired Healing1

Recent adverse event reports

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

  • InjuryOct 12, 2020Fracture; Fracture

    AS REPORTED: "[...] THE PATIENT UNDERWENT A REVISION SURGERY, ON (B)(6) 2014, AFTER A GAMMA NAIL IMPLANTATION IN 2013, DUE TO A REDUCTION OF FRACTURE OF THE LEFT FEMUR. ON (B)(6) 2014, A DELAY IN CONSOLIDATION AND BREAKING OF THE DEVICE WAS ASCERTAINED."

    Patient problems: Failure of Implant; Impaired Healing

    MAUDE report 10667354 ↗

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Sources and updates

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