Recall Z-1816-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
| Date | Jul 29, 2013 (initiated Oct 12, 2012) |
| Status | Open, Classified |
| Reason | It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional. |
| Root cause | Packaging |
| Action | Synthes sent a Urgent Notice Medical Device Recall letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is requesting that you please examine your inventory for products with the above Part and Lot number and remove them. Call Synthes at 1-800-479-6329. If you have any further questions please call 610-719-5450. |
| Quantity | 8 |
| Distribution | US 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 |