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 Recall Z-0606-2012 · Posted 2012-01-11
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeNPJ
Date Initiated2011-08-17
Date Terminated2014-03-26
Product Quantity26,648 units
Reason for Recall
Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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