Recall Z-0699-2025— MicroPort Orthopedics Inc.
Class II · Ongoing
Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2024-10-29. It names 3 FDA 510(k) clearances: K140735, K102380, K093552. 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: 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..
- Recalling firm
- MicroPort Orthopedics Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-29
- Firm location
- Arlington, TN, United States
510(k) clearances named in this recall
3 on FDA's record- K140735 — EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
- K102380 — EVOLUTION MP TOTAL KNEE SYSTEM
- K093552 — EVOLUTION MP TOTAL KNEE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.