Reported Sep 25, 2013 · Terminated

TWINFIX Ultra 5.5 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 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles
  • Part Number72202616 Biodegradable suture anchor
Lot codes and dates
    • 50373722
    • 50397580
    • 50397597
    • 50397602
    • 50397606
    • 50414780
    • 50418109
    • 50431745
    • 50431893
    • 50432157
    • 50438518
    • 50438520
    • 50447115
    • 50447117
    • 50447120
    • 50448228
    • 50449526
    • 50449671
    • 50450004
    • 50454012
    • 50454109
    • 50456362
    • 50459638
    • 50460185
    • 50462233
    • 50468656
    • 50469160
    • 50469533
Amount recalled
2038 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, 6:49 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.