FDA-Device2013-02-13Class II
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Allergen Medical
Hazard
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Sold states
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
Affected count
225 units (US) and 81 (Outside US)
Manufactured in
200 Boston Avenue, N/A, Medford, MA, United States
Products
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0794-2013Don't want to check this manually?
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