Symmetry KARLIN™ 46-3204Recalls & reported problems
Aspen Surgical Products, Inc. · Symmetry® Karlin Retractor; Crank Frame Blade; Left & Right; 4 in Long; 3/4 in Wide · Class 2
Data updated Oct 18, 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 00887482015070), received between Apr 27, 2022 and Apr 27, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2022Break
THE RETRACTOR HAD BEEN IN PLACE FOR APPROXIMATELY 20 MINUTES IN THE PATIENT WHILE THE SURGEON WAS WORKING WITHOUT INCIDENT. THE SURGICAL STAFF WAS PREPARING TO DRAPE THE PATIENT AND BRINGIN O-ARM FOR IMAGING, WHEN THE RETRACTOR BLADE SUDDLENLY BROKE INTO TWO PIECES. WHEN THE BLADE BROKE IT EJECTED ITSELF OUT OF THE PATIENT ONTO THE FLOOR. THE PATIENT WAS CHECKED FOR FRAGMENTS FROM THE BREAK WITH NOTHING FOUND INSIDE THE PATIENT. THERE WAS NO FURTHER IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14220136 ↗
Other Retractor, Self-Retaining, For Neurosurgery devices
- AURORA® Surgiscope® ASX15/60Integra Lifesciences Corporation · Retractor, Self-Retaining, For Neurosurgery1 recall1 report
- SPOTLIGHT 282915560Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY2 reports
- SPOTLIGHT 282918570Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- Symmetry KARLIN™ 46-3191Aspen Surgical Products, Inc. · Retractor, Self-Retaining, For Neurosurgery1 report
- Aurora® Surgiscope® ASX9/100Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- V. Mueller T-1295Steris Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- Budde® A1040Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- SPOTLIGHT 282924550Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
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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