Reported Sep 25, 2013 · Terminated

TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor

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 3 ULTRABRAID SuturePart
  • Number72202603 Biodegradable suture anchor
Lot codes and dates
  • 64 of 64 codes

    • 50324716
    • 50324717
    • 50326836
    • 50336720
    • 50336769
    • 50337108
    • 50337111
    • 50339644
    • 50339652
    • 50339655
    • 50339836
    • 50340060
    • 50341066
    • 50341289
    • 50341609
    • 50341853
    • 50342712
    • 50344393
    • 50345532
    • 50349940
    • 50375176
    • 50377968
    • 50378734
    • 50380398
    • 50382028
    • 50385516
    • 50386564
    • 50387848
    • 50391713
    • 50392430
    • 50395097
    • 50395980
    • 50396847
    • 50399973
    • 50400923
    • 50402846
    • 50405227
    • 50406208
    • 50406714
    • 50408995
    • 50410652
    • 50411391
    • 50412536
    • 50415225
    • 50415871
    • 50416543
    • 50417398
    • 50428649
    • 50429274
    • 50429621
    • 50429622
    • 50429871
    • 50436765
    • 50436775
    • 50437663
    • 50440391
    • 50443629
    • 50446032
    • 50446451
    • 50446454
Amount recalled
N/A

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, 6:16 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.