Reported Sep 25, 2013 · Terminated

TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable…

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 PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture
  • White / BlackPart
  • Number72202602 Biodegradable suture anchor
Lot codes and dates
  • 138 of 138 codes

    • 50324714
    • 50324959
    • 50325405
    • 50336718
    • 50336766
    • 50337107
    • 50337110
    • 50339396
    • 50339650
    • 50339654
    • 50339835
    • 50340055
    • 50341065
    • 50341288
    • 50341608
    • 50341852
    • 50341974
    • 50343277
    • 50344392
    • 50345531
    • 50346096
    • 50349836
    • 50350192
    • 50351792
    • 50355983
    • 50356629
    • 50357082
    • 50358377
    • 50358556
    • 50359999
    • 50360659
    • 50361740
    • 50362632
    • 50363174
    • 50363872
    • 50366312
    • 50367556
    • 50368583
    • 50369516
    • 50370078
    • 50370505
    • 50371296
    • 50371908
    • 50372043
    • 50372901
    • 50373581
    • 50376024
    • 50376595
    • 50377415
    • 50378045
    • 50378652
    • 50379636
    • 50379935
    • 50381013
    • 50381052
    • 50382145
    • 50383363
    • 50384738
    • 50384957
    • 50385695
Amount recalled
7148 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, 6:15 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.