Aero-AL 48922200Recalls & reported problems
Stryker Corporation · Fixation Anchor, Blue Cartridge · Class 2 · Implant
All models of Aero-AL (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327065572), received between Feb 16, 2016 and Feb 16, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
- Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2016Break; Difficult to Remove; Sticking; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING THE CASE THE BOTTOM LEFT ANCHOR GOT STUCK IN THE INSERTER AND WOULD NOT ADVANCE INTO THE BONE AND DEFORMED SIGNIFICANTLY. OSTEOPHYTES WERE PRESENT AND THE PILOT CUTTER WAS USED. THE CUTTER TIP WAS VISIBLY DAMAGED. IT WAS INCREDIBLY DIFFICULT TO UNTHREAD THE INSIDE SHAFT TO REMOVE THE INSERTER FROM THE CAGE. THE DAMAGED ANCHOR WAS RETRIEVED AND THE CASE WAS COMPLETED WITH 3 ANCHORS IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5439393 ↗
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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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