Z-0275-2023Class II

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

Name: Z-0275-2023 EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Creator: MicroPort Orthopedics Inc.
Published: 2022-10-28
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2022-10-28 / Open, Classified / root cause: manufacturing process

FDA source

MicroPort Orthopedics Inc. began a recall of EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base on 2022-10-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0275-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-28
Posted: 2022-11-22
Recalling firm: Microport Orthopedics Inc.
Product: EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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: [email protected]"
Quantity in commerce: 24 units
Distribution: International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Product codes and lots: UDI/DI 0 0192629 08287 8, Lot 1916559

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0275-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2022-11-22
Z-0276-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2022-11-22

Product code HRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)