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Recall Observatory FDA recall evidence

Device product

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

Z-0731-2020

January 25, 2019

Class III

Product summary

Firm
AAP Implantate Ag
Event
Event 84383
Status
Terminated
Classification
Class III
Quantity
2 units
Official record key
device-enforcement:Z-0731-2020

Official wording

Reason: Products were distributed with the incorrect instructions for use.

Code information: Lot Code: QR0013

Distribution pattern: Texas

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products were distributed with the incorrect instructions for use.