EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

FDA device recall Z-0275-2023 · posted 2022-11-22 · Open, Classified

Recall details

Recalling firm

MicroPort Orthopedics Inc.

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.

Action taken

MicroPort 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"

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

HRY

Quantity affected

24 units

Distribution

International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

Date initiated

2022-10-28

Date posted

2022-11-22

Location

Arlington, TN

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