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Recall Observatory FDA recall evidence

Device product

Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty

Z-0980-2019

January 21, 2019

Class II

Product summary

Firm
Stryker GmbH
Event
Event 82140
Status
Terminated
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-0980-2019

Official wording

Reason: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.

Code information: Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)

Distribution pattern: In the countries of Canada and Korea

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.