Z-1249-2015Class II

EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx...

Name: Z-1249-2015 EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx...
Creator: Microport Orthopedics INC.
Published: 2015-02-02
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2015-02-02 / Terminated / root cause: design

FDA source

Microport Orthopedics INC. began a recall of EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis... on 2015-02-02. FDA classified it as Class II and gives the reason as "Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1249-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-02
Posted: 2015-03-06
Terminated: 2015-03-19
Recalling firm: Microport Orthopedics Inc.
Product: EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Root cause tag: design
FDA root cause: Device Design
Action: MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.
Quantity in commerce: 17 units
Distribution: Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
Product codes and lots: Lot Numbers: 1560140, 15601401568897, 15601401570896

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1249-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1249-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code JWH

K093552Class IIEvolution Mp Total Knee SystemWrightmedicaltechnologyinc / cleared 2010-03-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)