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Recall Observatory FDA recall evidence

Device product

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

Z-1951-2021

May 19, 2021

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 88010
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1951-2021

Official wording

Reason: The device components experienced a manufacturing process error that resulted in surface damage from product handling.

Code information: Lot 20HM17607

Distribution pattern: US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing process error