Wagner SL Revision® 01.00109.810Recalls & reported problems
Zimmer GmbH · Class 2
All models of Wagner SL Revision (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024278011), received between Jul 30, 2021 and Dec 2, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Most reported problems
Device problems
- Mechanical Jam2
- Mechanical Problem2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2021Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam
IT WAS REPORTED THAT WHEN TAKING STEM OFF OF THE NECK, THE TRIAL SCREW BECAME STUCK IN THE NECK. WHILE TRYING TO GET THE SCREW OUT, IT BECAME STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12915054 ↗MalfunctionJul 30, 2021Fracture; Mechanical Problem; Mechanical Jam; Fracture; Mechanical Problem; Mechanical Jam
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12251493 ↗
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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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