Reported Dec 18, 2013 · Terminated
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended…
Ethicon, Inc.
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: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
- Lot codes and dates
- K113004 D183642 All product codes beginning with SXPP1A.
- Amount recalled
- 37,164 eaches
Where it was sold
- Nationwide
Why it was recalled
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
This product could cause temporary or reversible health problems — stop using it.
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