Symmetry Classic Plus® 36-2025Recalls & reported problems
Aspen Surgical Products, Inc. · Classic Plus® Needle Holder, Sternal, 7 in, 178 mm · Class 1
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 00887482009772), received between Sep 15, 2015 and Dec 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Entrapment of Device1
- Insufficient Device Problem Information1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2019Entrapment of Device; Device Dislodged or Dislocated
AT THE CONCLUSION OF THE PROCEDURE, WHEN PLACING THE STERNAL WIRES, THE "INSERT" FROM THE STERNAL WIRE NEEDLE DRIVER BECAME DISLODGED FROM THE INSTRUMENT AND WAS RETAINED IN THE PATIENT'S CHEST. PER X-RAY, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO PARTIALLY REOPEN THE CHEST WALL TO REVOLVE THE PIECE. AS A RESULT, THE PATIENT REMAINED IN THE HOSPITAL FOR TWO ADDITIONAL INPATIENT ADMISSION DAYS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9511537 ↗Sep 15, 2015Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
NEEDLE INSERT CAME APART AND FELL INSIDE THE PATIENT. NO HARM TO PATIENT. DEVICE WAS MANUFACTURED IN (B)(6) 2011. THE INSERTS WERE REPAIRED UNDER WARRANTY IN (B)(6) 2013.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5100896 ↗
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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