Recall Z-0606-2012 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
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 o
| Date | Jan 11, 2012 (initiated Aug 17, 2011) |
| Status | Terminated |
| Reason | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. |
| 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 | 26,648 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp., Dec 27, 2005 |