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Recall Observatory FDA recall evidence

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

February 19, 2014

Class II

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

    reason.labeling_packaging · v1.0.0

    incomplete seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seal on the packaging compromised the sterility