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Recall Observatory FDA recall evidence

Device product

Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

Z-1778-2022

August 24, 2022

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 90836
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1778-2022

Official wording

Reason: A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

Code information: Lot number B24694 (no UDI)

Distribution pattern: Distributed to one customer located in New York.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.