GAMMA 3525-1300SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252274254), received between Sep 9, 2019 and May 5, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break2
Patient problems
- Failure of Implant1
- Implant Pain1
- No Information1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2025Break; Fracture; Break; Fracture
AS REPORTED: "IMPLANT FRACTURE AFTER NON-CONSOLIDATED FRACTURE. EXPLANTATION OF THE BROKEN IMPLANT, IMPLANTATION OF A HIP TEP.".
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21960140 ↗InjuryJun 11, 2024Break; Fracture; Break; Fracture
AS REPORTED: "11 MM HAMMER NAIL WITH NAIL FRACTURE IN THE AREA OF THE FEMORAL HEAD SCREW HOLE. THIS WAS A SPONTANEOUS FRACTURE. PATIENT PRESENTED WITH PAIN. REVISION SURGERY ON 14.05.24 WITH 13 MM GAMMA NAIL AND TROCHANTERIC HOOK PLATE."
Patient problems: Failure of Implant; Implant Pain
MAUDE report 19515099 ↗InjurySep 9, 2019Fracture; Fracture
AS REPORTED: "BREAKAGE OF THE GAMMA 3 NAIL. NAIL HAS TO BE REMOVED. EXACT EVENT DATE IS UNKNOWN. REVISION SURGERY ON (B)(6) 2019."
Patient problems: No Information
MAUDE report 8974116 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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