HI-FI 8536 (UDI 10653405002048)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405002048), received between May 11, 2021 and May 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K100006); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2021Break; Break

  ACCORDING TO THE REPORTER, "THE NEEDLE BROKE DURING USE WITHOUT THE SURGEON'S KNOWLEDGE AND FRAGMENT WAS INADVERTENTLY LEFT IN THE PATIENT." REPORTER ALSO NOTED THAT THE "PATIENT UNDERWENT SURGERY PERFORMED BY <> TO REMOVE THE METAL WHICH TURNED OUT TO BE A PORTION OF A MENISCUS REPAIR NEEDLE. IT WAS SUCCESSFULLY EXTRACTED."

  Patient problems: Burning Sensation; Foreign Body In Patient; Pain

  MAUDE report 11805737 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100006. One submission often covers many models, so check the product and lot details in each record.

• Z-2761-2016 · Aug 5, 2016 · Terminated
  Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For u
• Z-2762-2016 · Aug 5, 2016 · Terminated
  Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, inc