Titanium IntraLine 3910-400-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154890088), received between Jan 16, 2020 and Aug 22, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionAug 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PLACEMENT OF A SHOULDER ANCHOR, IT BROKE, WITH HALF OF THE ANCHOR REMAINING IN THE BONE AND THE OTHER HALF OUTSIDE THE BONE, FOR NO APPARENT REASON. THE DEPARTMENT CLAIMS THAT THE BROKEN FRAGMENTS REMAINING IN THE PATIENT WERE REMOVED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877009 ↗
• InjuryJan 16, 2020Defective Component; Detachment of Device or Device Component; Defective Component

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO THE SUTURES PULLING OUT OF THE ANCHOR POST-OP.

  Patient problems: Failure to Anastomose

  MAUDE report 9596532 ↗
• InjuryJan 16, 2020Defective Component; Detachment of Device or Device Component; Defective Component

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO THE SUTURES PULLING OUT OF THE ANCHOR POST-OP.

  Patient problems: Failure to Anastomose

  MAUDE report 9596530 ↗

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-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.
• 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-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-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.