Symmetry Classic Plus® 36-3010Recalls & reported problems
Aspen Surgical Products, Inc. · Classic Plus® Needle Holder, Microvascular, 7 in · Class 1
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 00887482009871), received between May 23, 2023 and May 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
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.
MalfunctionMay 23, 2023Material Fragmentation; Material Fragmentation
THE CUSTOMER ALLEGED THAT THE PATIENT WAS UNDERGOING A BIFRONTAL CRANIOTOMY. AT THE TIME IF CLOSURE, A CLASSIC PLUS NEEDLE HOLDER WAS BEING USED TO PLACE SUTURES FOR DURAL CLOSURE. DURING THE PLACEMENT OF THE SUTURE A PORTION OF THE JAW PLATE BROKE AWAY FROM THE NEEDLE HOLDER AND THE FRACTURED PORTION OF THE JAW PLATE UNKNOWINGLY FELL INTO THE SURGICAL BED. THIS WAS NOT NOTICED BY THE SURGICAL TEAM, NOR THE OR STAFF INTRAOPERATIVELY, AND CLOSING CONTINUED. THE PROCEDURE WAS FINISHED WITHOUT ISSUES. POST PROCEDURE, THE PATIENT UNDERWENT ROUTINE POSTOPERATIVE HEAD CT WHERE A METALLIC OBJECT WAS IDENTIFIED WITHIN THE SURGICAL BED. THE SURGICAL TEAM DETERMINED THIS WAS NOT AN INTENTIONALLY PLACED SURGICAL ITEM. IT WAS DECIDED BY THE SURGICAL TEAM TO TAKE THE PATIENT BACK TO THE OR THE NEXT DAY TO RETRIEVE THE UNKNOWN RETAINED ITEM. ONCE THE SURGICAL WOUND WAS REOPENED, THEY IDENTIFIED THE OBJECT AS A 9MM CARBIDE PIECE OF THE NEEDLE HOLDER JAW PLATE. THE DEFECTIVE NEEDLE WAS LOCATED, AND THE PIECE WAS RETRIEVED FROM THE PATIENT. THE PIECE FIT THE INSTRUMENT WHICH CONFIRMED THERE WERE NO ADDITIONAL MISSING PIECES. AN ADDITIONAL HEAD IMAGING WAS OBTAINED TO VERIFY THAT NO OTHER METALLIC I
Patient problems: Foreign Body In Patient
MAUDE report 16988862 ↗
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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