FDA recall Z-0699-2025

Product

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

Reason for recall

Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

Distribution

OUS: CN, GR, ES, ZA, FR, JP, IT

Key facts

Status

Ongoing

Initiation date

2024-10-29

Report date

2024-12-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0699-2025