GAMMA 8525-2380SRecalls & reported problems
Stryker GmbH · Long Nail, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 18, 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 07613327475234), received between Oct 7, 2024 and Nov 12, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- Failure of Implant1
- Insufficient Information1
- 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.
InjuryNov 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A LONG GAMMA NAIL WAS REMOVED. FAILURE HAPPENED AT THE LAB SCREW INTERFACE. IMPLANT WAS IMPLANTED IN (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 23535808 ↗InjuryOct 7, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED BECAUSE POSTOPERATIVELY THE GAMMA4 LONG NAIL WAS BROKEN AND REQUIRES A REVISION. REVISION SURGERY IS PLANNED ON (B)(6).
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 20392451 ↗
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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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