Reported Sep 25, 2013 · Terminated

TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 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 HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue
  • Part Number72202597 Biodegradable suture anchor
Lot codes and dates
  • 86 of 86 codes

    • 50324706
    • 50324707
    • 50324958
    • 50325148
    • 50326624
    • 50336118
    • 50336716
    • 50336759
    • 50337105
    • 50337109
    • 50337112
    • 50339394
    • 50339648
    • 50339653
    • 50339656
    • 50339873
    • 50341613
    • 50343278
    • 50344410
    • 50346095
    • 50350419
    • 50352199
    • 50357080
    • 50358106
    • 50358736
    • 50359998
    • 50361739
    • 50362786
    • 50363871
    • 50366812
    • 50368582
    • 50370504
    • 50372042
    • 50374257
    • 50376594
    • 50378774
    • 50380528
    • 50382637
    • 50384518
    • 50386924
    • 50388022
    • 50390005
    • 50390988
    • 50392388
    • 50395082
    • 50395975
    • 50396667
    • 50398098
    • 50401255
    • 50402220
    • 50404745
    • 50406626
    • 50406675
    • 50408537
    • 50411606
    • 50414330
    • 50415861
    • 50417004
    • 50418086
    • 50422213
Amount recalled
8889 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, 4:49 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.