Reported Sep 25, 2013 · Terminated

TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part…

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?

  • TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles
  • Part Number72202612 Biodegradable suture anchor
Lot codes and dates
    • 50373723
    • 50389654
    • 50389655
    • 50397577
    • 50397596
    • 50397599
    • 50397605
    • 50417226
    • 50431744
    • 50431853
    • 50433695
    • 50437528
    • 50440608
    • 50441690
    • 50447116
    • 50447118
    • 50447119
    • 50448227
    • 50454009
    • 50454867
    • 50461412
    • 50467503
    • 50469159
    • 50470653
Amount recalled
1571 US

This recall covers 26 products

The agency filed one notice per product. You are reading one of them; the other 25 are below.

13 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

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

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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 20, 2016 · Data as of Sep 19, 5:31 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.