—#106058

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.

FDA product code: NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052917
Affected lot / code info: 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

Why it was recalled

Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2011-08-17
Posted by FDA: 2012-01-11
Terminated: 2014-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.