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Recall Observatory FDA recall evidence

Device product

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

Z-0139-2023

September 30, 2022

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 90965
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0139-2023

Official wording

Reason: The tibial tray lock detail is oversized (larger than specification).

Code information: GTIN 00840420124142, Lot Code: 1726308

Distribution pattern: US Nationwide distribution in the state of New York.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The tibial tray lock detail is oversized (larger than specification).