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U.S. Department of Health and Human Services

Class 2 Device Recall EVOLUTION MP Femoral CS/CR NonPorous

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 Class 2 Device Recall EVOLUTION MP Femoral CS/CR NonPoroussee related information
Date Initiated by FirmMay 03, 2024
Date PostedJuly 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2244-2024
Recall Event ID 94729
510(K)NumberK093552 K102380 
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
ProductEVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Code Information UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact
901-867-9971
Manufacturer Reason
for Recall		One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe recalling firm issued the FSN, dated 05/02/2024, via email. The required actions were to: Immediately check inventory and quarantine all subject product(s); COMPLETE AND RETURN the attached FSCA Acknowledgement; Inform MicroPort Orthopedics of any adverse event immediately; Return any affected product to: MicroPort Orthopedics Inc. 1481 Gulf Stream, Arlington, TN 38002. The consignee is to mark all return shipping boxes with RECALL on several sides for better identification and processing.
Quantity in Commerce40 units
DistributionInternational distribution in the country of China. There is no field inventory in the United States for either lot.
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 = HRY
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