Z-0606-2012

Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L...

Name: Z-0606-2012 Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-08-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-08-17 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for... on 2011-08-17. The reason FDA records is "Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0606-2012
Status: Terminated
Initiated: 2011-08-17
Posted: 2012-01-11
Terminated: 2014-03-26
Recalling firm: Howmedica Osteonics Corp
Product: Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone.
Product code: NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
FDA root cause: Other
Action: Stryker Orthopaedics sent "URGENT PRODUCT RECALL" letters dated August 17, 18 and 25, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgement Form via fax to 201-831-6069. Contact the firm at 201-972-2100 for questions concerning this recall.
Quantity in commerce: 26,648 units
Distribution: Nationwide Distribution.
Product codes and lots: K052917, K9922887 6636-2-001 002,003, 004, 005, 011, 012, 013, 014, 015, 308, 309, 310, 312, 318, 319, 320, 322, 408, 409, 410, 412, 418, 419, 420, 422, 508, 509, 510, 512, 518, 519, 520, 522, 608, 609, 610, 612, 618, 619, 620, 622, 708, 709, 710, 712, 718, 719, 720, and 722 - ALL LOTS

Product code NPJ

K052917Class IIStryker Compartmental Knee SystemHowmedica Osteonics Corp. / cleared 2005-12-27

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)