Skip to content

Eius Unicompartmental Knee System recallZ-0606-2012 · Stryker Howmedica Osteonics Corp. · initiated Aug 17, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0606-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 17, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
26,648 units
Product code
NPJ
FDA submissions
K052917
Distribution
Nationwide Distribution.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

8 devices cleared under K052917 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page