Device product
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.
Z-1329-2014
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 67736
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 223 units
- Official record key
device-enforcement:Z-1329-2014
Official wording
Reason: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Code information: Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
seal on the packaging compromised the sterility