GAMMA 3530-0340SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540375865), received between Jun 2, 2022 and Aug 7, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- Failure of Implant2
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2024Break; Fracture; Break; Fracture
NAIL BREAKAGE OCCURRED. A LONG GUN NAIL WAS BROKEN DUE TO A PSEUDOJOINT. REVISION SURGERY IS PLANNED.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 19929407 ↗InjuryJun 2, 2022Break; Fracture; Break; Fracture
AS REPORTED: "GAMMA NAIL IS BROKEN. THE PATIENT REQUIRED REVISION SURGERY."
Patient problems: Failure of Implant
MAUDE report 14572511 ↗
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- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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