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Recall Observatory FDA recall evidence

Device product

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

Z-0967-2019

December 19, 2018

Class II

Product summary

Firm
Cook Inc.
Event
Event 81979
Status
Terminated
Classification
Class II
Quantity
797
Official record key
device-enforcement:Z-0967-2019

Official wording

Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

Code information: Lot numbers 8144390,8159665, 8173295, 8204594, 8261263,8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X

Distribution pattern: Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.