Recall Z-2451-2015 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes (USA) Products LLC
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that
| Date | Aug 24, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported. |
| Root cause | Labeling design |
| Action | Urgent recall letters, dated July 31, 2015, were sent to end users and sales consultants to notifiy them about the issue, the associated risks, and to provide instructions for returning the affected devices and response form. |
| Quantity | 5306080 |
| Distribution | Worldwide Distribution-including US (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 |
| K031428 | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE Synthes (Usa), Aug 8, 2003 |
| K033158 | SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES Synthes (Usa), Nov 5, 2003 |
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Synthes (Usa), Nov 18, 2008 |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM Synthes, Apr 11, 2013 |