Reported Aug 15, 2012 · Terminated

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles…

Smith & Nephew, Inc. Endoscopy Division

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. Endoscopy Division · 150 Minuteman Drive · Andover, MA · 01810-1031

Is this the product you have?

  • Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID)
  • with Needles Product Usageintended for use for the reattachment
  • of soft tissue to bone Part Number72202618
Lot codes and dates
  • Lot Numbers
    • 50396501
    • 50396505
    • 50396506
    • 50397570
    • 50408062
    • 50412964
    • 50416842:
Amount recalled
913 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Distal part of the anchor may break on insertion into bone during surgery

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 18, 2016 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.