AXSOS 627614Recalls & reported problems
Stryker GmbH · Distal Lateral Femur Plate · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 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 07613252579595), received between Jan 5, 2021 and Jan 15, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break1
Patient problems
- Failure of Implant2
- Insufficient 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.
InjuryJan 15, 2026Fracture
A BROKEN 14 HOLE FEMUR PLATE WAS REMOVED AND REPLACED WITH STAINLESS STEEL AXSOS DISTAL FEMURE PLATE 16 HOLE.
Patient problems: Insufficient Information
MAUDE report 24082032 ↗InjurySep 4, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT: "SURGICAL REVISION OF A PATIENT INITIALLY OPERATED ON (B)(6) 2024 FOR OSTEOSYNTHESIS OF THE LEFT DISTAL FEMUR BY PLACEMENT OF STRYKER PLATE REF: 627614S BATCH: AB9962. SURGICAL REVISION FOR REMOVAL OF STRYKER MATERIAL DUE TO PLATE RUPTURE AND RE-INSTALLATION OF ZIMMER MATERIAL. REHOSPITALIZATION AND HIGH-RISK POSTOPERATIVE CARE IN AN ELDERLY PATIENT."
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 20141257 ↗InjuryJan 5, 2021Fracture; Fracture
AS REPORTED: "AXSOS 3 DISTAL FEMUR LEFT 14 HOLE PLATE BROKE AT A SCREW HOLE. NEEDED A REVISION SURGERY."
Patient problems: Failure of Implant
MAUDE report 11121139 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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