Recall Z-0277-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic
| Date | Nov 13, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 8 |
| Distribution | Nationwide Distribution-including the states of CA, MN, NC, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Synthes (Usa), Nov 18, 2008 |