Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business
FDA device recall Z-0606-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.
- Action taken
- 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
- Status
- Terminated
- Product code
- NPJ
- Quantity affected
- 26,648 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-08-17
- Date posted
- 2012-01-11
- Date terminated
- 2014-03-26
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER COMPARTMENTAL KNEE SYSTEM (K052917) | Howmedica Osteonics Corp. | 2005-12-27 |