Recall Z-1833-2014 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
| Date | Jun 19, 2014 (initiated Apr 10, 2014) |
| Status | Terminated |
| Reason | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. |
| Root cause | Labeling Change Control |
| Action | Synthes sent an Urgent Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: All Synthes External Fixation devices should be treated as MR Conditional. " Synthes asks that you review the information contained in this Labeling Notification and complete the Verification Section located on Page 3. " Discard outdated revisions of the Technique Guides noted in the table below. " Update your records with updated Labeling Infonnation. " Forward this Medical Device Labeling Upd |
| Quantity | 5,114,052 |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030390 | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE Synthes (Usa), Apr 1, 2003 |
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Synthes (Usa), Nov 18, 2008 |
| K090658 | SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL Synthes (Usa), Mar 3, 2010 |
| K092190 | SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS Synthes (Usa), May 11, 2010 |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM Synthes, Apr 11, 2013 |