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
This recall is currently active, issued December 18, 2024. It was issued by Microport Orthopedics Inc..
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- October 29, 2024
- Posted
- December 18, 2024
- Recall Number
- Z-0699-2025
- Quantity
- 32
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
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
Lot / Code Info
REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Root Cause
Labeling Change Control
Action Taken
On 10/29/24 field safety notices were emailed to customers who were asked to do the following: 1) Check inventory and quarantine all subject product(s) 2) Return affected products 3) Complete and return the acknowledgement form via email to PostMarket@ortho.microport.com For questions or additional information please contact the firm at: +31 20 545 01 00, or PostMarket@ortho.microport.com