FDA-Device2021-06-30Class II
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.
Smith & Nephew, Inc.
Hazard
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Sold states
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Affected count
5 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1951-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief