Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16596 |
| Brand Name: | Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies |
| Model: | Models: 04.315.064 and 04.315.066 |
| Affected: | Lots: 6342004, 7351857 and 6651388, 6913921, 718588 respectivly |
| Software version: | |
| Recalling Organisation: | Synthes New Zealand Ltd 507 Mt Wellington Highway Mt Wellington Auckland 1060 |
| Contact Information: | 0800 657 734 |
| Manufacturer: | Synthes GmbH |
| Issue: | The AB and BC Distractor Bodies used in the Craniomaxillofacial Distraction System may reverse post-operatively. In the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. In some instances, revision surgery may be needed to replace the device. Reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 14/5/2014 |
