FDA-Device2014-04-09Class II
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Ethicon, Inc.
Hazard
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Sold states
US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.
Affected count
223 units
Manufactured in
US Highway 22 West, N/A, Somerville, NJ, United States
Products
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2014Don't want to check this manually?
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