The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.
FDA device recall Z-1009-2015 · posted 2015-01-23 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
- Action taken
- Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MQN
- Quantity affected
- 43159
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-10-17
- Date posted
- 2015-01-23
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES MANDIBLE EXTERNAL FIXATOR (K050378) | Synthes (Usa) | 2005-03-15 |
| SYNTHES MANDIBLE EXTERNAL FIXATOR (K040169) | Synthes (Usa) | 2004-04-14 |