Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long
FDA device recall Z-0277-2013 · posted 2012-11-13 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
- Action taken
- Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated September 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Verification Form via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this notice.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 8
- Distribution
- Nationwide Distribution-including the states of CA, MN, NC, and TN.
- Date initiated
- 2012-09-28
- Date posted
- 2012-11-13
- Date terminated
- 2015-09-21
- 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 LARGE EXTERNAL FIXATION, MR CONDITIONAL (K082650) | Synthes (Usa) | 2008-11-18 |