BIORAPTOR 72201542Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010595089), received between Feb 20, 2023 and Sep 16, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K071586, K152566, K251627); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 29, 2024Open, Classified

   Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

   Z-0581-2025 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE ANCHOR TIP OF THE BIORAPTOR SUTURE ANCHOR WAS PENETRATING THROUGH THE PACKAGING, IT WAS NO LONGER STERILE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225387 ↗
• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIORAPTOR SUTURE PK ANCHOR BROKE WHEN INSERTING INTO THE PREPARED CHANNEL. THE COMPONENTS WERE REMOVED FROM THE JOINT. THE ORIGINAL BONE HOLE WAS USED. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126453 ↗
• InjuryFeb 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORAPTOR ANCHOR GOT BROKEN WHILE INSERTING INSIDE THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071586, K152566, K251627. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.