FDA recall Z-1951-2021

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-05-19

Report date

2021-06-30

Termination date

2023-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1951-2021