Symmetry Classic Plus® Mayo-Hegar 36-2016Recalls & reported problems
Aspen Surgical Products, Inc. · Classic Plus® Needle Holder, Mayo-Hegar, 6 in, 152 mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887482009703), received between Dec 10, 2020 and Dec 10, 2020 — classified as 1 injury.
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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2020Break
THE CUSTOMER ALLEGED THAT THE PATIENT UNDERWENT A CRANIOTOMY FOR EPIDURAL HEMATOMA REMOVAL. UPON POST-OPERATIVE CT SCANS, IT WAS NOTED THAT THERE WAS A METALLIC DENSITY SEEN OVER THE BONE IN THE SUBGALEAL SPACE. UPON INVESTIGATION THE INSTRUMENT KIT USED FOR THE PROCEDURE WAS OBTAINED AND IT WAS DISCOVERED THAT THERE WAS A BROKEN NEEDLE HOLDER. THE PIECE WAS NOT ABLE TO BE RETRIEVED DUE TO AN UNRELATED HEALTH CONDITION.
Patient problems: Foreign Body In Patient
MAUDE report 10985163 ↗
Other Holder, Needle; Orthopedic devices
- Sklar Instruments 96-2581Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2585ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2583ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2586Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2740ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2710Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2711ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2745ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
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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