ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. For cemented use o
FDA device recall Z-1623-2009 · posted 2009-07-15 · Terminated
Recall details
- Recalling firm
- Conformis Inc
- Reason for recall
- Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
- Action taken
- ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted. Contact ConforMIS for further questions at 1-781-345-9164.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 6 units
- Distribution
- Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
- Date initiated
- 2009-04-23
- Date posted
- 2009-07-15
- Date terminated
- 2009-10-14
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONFORMIS METAL BACKED TIBIAL COMPONENT (K072368) | Conformis, Inc. | 2007-09-20 |
| CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) (K063432) | Conformis, Inc. | 2007-03-16 |
| UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD (K043570) | Conformis, Inc. | 2005-03-14 |