Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacemen
FDA device recall Z-0581-2015 · posted 2014-12-11 · Terminated
Recall details
- Recalling firm
- ConforMIS, Inc.
- Reason for recall
- Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
- Action taken
- Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- Distributed to IN.
- Date initiated
- 2014-11-19
- Date posted
- 2014-12-11
- Date terminated
- 2015-10-08
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K140423) | Conformis, Inc. | 2014-05-27 |