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U.S. Department of Health and Human Services

Class 2 Device Recall EVOLUTION MP FEMORAL COMPONENT

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 Class 2 Device Recall EVOLUTION MP FEMORAL COMPONENTsee related information
Date Initiated by FirmOctober 29, 2024
Date PostedDecember 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0699-2025
Recall Event ID 95672
510(K)NumberK093552 K102380 K140735 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
ProductEVOLUTION 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
Code Information REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact
901-867-9971
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 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
Quantity in Commerce32
DistributionOUS: CN, GR, ES, ZA, FR, JP, IT
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MBH
510(K)s with Product Code = MBH
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