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Recall Observatory FDA recall evidence

Device product

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

Z-0287-2024

September 13, 2023

Class II

Product summary

Firm
Stryker Corporation
Event
Event 93140
Status
Ongoing
Classification
Class II
Quantity
19 kits
Official record key
device-enforcement:Z-0287-2024

Official wording

Reason: Expired product distributed

Code information: Lot # 007047/UDI: 07613252632863

Distribution pattern: US: NH, TX, NY, NJ, OH, MN OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Expired product distributed