Reported Jul 23, 2014 · Terminated
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
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?
- SUTUREFIX Ultra
- S Double Loaded Suture Product Code72203854 Fastener, fixation, nondegradable, soft tissue
- Lot codes and dates
- Lot Numbers
50478984504857365048573750485738504878315049190150493684
- Lot Numbers
- Amount recalled
- 763 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterility of device is compromised due to breach in sterile barrier
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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