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U.S. Department of Health and Human Services

Class 2 Device Recall MicroPort Evolution

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 Class 2 Device Recall MicroPort Evolutionsee related information
Date Initiated by FirmOctober 28, 2022
Date PostedNovember 22, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0275-2023
Recall Event ID 91102
510(K)NumberK093552 K102380 
Product Classification Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
ProductEVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Code Information UDI/DI 0 0192629 08287 8, Lot 1916559
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 ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMicroPort Orthopedics Disseminated Urgent Field Safety Notices to its consignees on October 28, 2022 via email. The notices explained the issue, the risk, and requested the following: "ACTIONS TO BE TAKEN BY THE USER: Our records indicate that you did receive the above referenced product: - Immediately check inventory and quarantine all subject products - COMPLETE AND RETURN the attached FSCA Acknowledgement - Inform MicroPort Orthopedics of any adverse event immediately - Return any affected product to MicroPort Orthopedics, please see your local distributor for details TRANSMISSION OF THIS NOTICE: This notice needs to be passed on to all those who need to be aware within your organization. CONTACT REFERENCE PERSON: For questions or additional information please contact: MicroPort Scientific Coperatief U.A. Phone: +31 20 545 01 00 Email: PostMarket@ortho.microport.com"
Quantity in Commerce24 units
DistributionInternational Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
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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