Reported Aug 15, 2012 · Terminated

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number:…

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 Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack)
  • sterile Part Number72202896
  • Product Usageintended for use for the reattachment of soft tissue to bone
Lot codes and dates
  • Lot Numbers
    • 50388182
    • 50389253
    • 50391626
    • 50392272
    • 50392407
    • 50395081
    • 50395680
    • 50396197
    • 50400556
    • 50401558
    • 50402228
    • 50403940
    • 50406036
    • 50407582
    • 50409406
    • 50413407
    • 50414970
    • 50412647
    • 50415864
    • 50416801
    • 50418088
    • 50420654
    • 50421030
    • 50421495
Amount recalled
2,204 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, 5:24 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.