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Recall Observatory FDA recall evidence

Device product

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

Z-0078-2019

August 29, 2018

Class II

Product summary

Firm
Incisive Surgical Inc
Event
Event 81008
Status
Terminated
Classification
Class II
Quantity
1200 units
Official record key
device-enforcement:Z-0078-2019

Official wording

Reason: Possible compromise of the sterile barrier integrity

Code information: UDI 10867516000101 Lot Number 182801

Distribution pattern: Israel

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible compromise of the sterile barrier integrity