Z-1951-2021 Class II Terminated

Recalled by Smith & Nephew, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
June 30, 2021
Initiation Date
May 19, 2021
Termination Date
April 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

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 Pattern

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

Code Information

Lot 20HM17607