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Recall Observatory FDA recall evidence

Device product

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Z-0488-2023

November 02, 2022

Class II

Product summary

Firm
Stradis Medical, LLC dba Stradis Healthcare
Event
Event 91124
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-0488-2023

Official wording

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Code information: UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516

Distribution pattern: US nationwide distribution, and Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    bag being incompletely sealed, which may result in a breach
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    bag being incompletely sealed, which may result in a breach in the sterility