Titanium IntraLine 3910-400-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154890071), received between Jun 14, 2019 and May 11, 2021 — classified as 1 injury, 2 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K071157); 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 18, 2026.

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.

• MalfunctionMay 11, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805434 ↗
• MalfunctionMay 11, 2021Contamination; Delivered as Unsterile Product; Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805310 ↗
• InjuryJun 14, 2019Crack

  IT WAS REPORTED THAT THE ANCHOR PLACEMENT CAUSED A CRACK IN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8700911 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071157. One submission often covers many models, so check the product and lot details in each record.

• Z-0618-2011 · Aug 20, 2009 · Terminated
  Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
• Z-1536-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tissue fixation to bone in certain areas.
• Z-1533-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.
• Z-1534-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for tissue fixation to bone in certain areas.
• Z-1535-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.