FDA Medical devices recall ·
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY recall
- Recall number
- Z-0699-2025
- Date
- (initiated October 29, 2024)
- Company / brand
- MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Distribution
OUS: CN, GR, ES, ZA, FR, JP, IT
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0699-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.