Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18229 |
| Brand Name: | Synthes Insert for DHS/DCS Impactor No. 338.260, single |
| Model: | Part Number: 338.260 |
| Affected: | All lots below 7985313 |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (NZ) Limited 13a Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Synthes GmbH |
| Brand Name: | Synthes DHS/DCS Impactor |
| Model: | 338.280 |
| Affected: | All lots below 7985313 |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (NZ) Limited 13a Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Synthes GmbH |
| Issue: | The DHS/DCS Impactor is composed of two parts: a replaceable plastic tip which is the Insert for DHS/DCS Impactor (338.260), and a metallic shaft (338.280). No biocompatibility testing has ever been completed by the manufacturer, Synthes, for the material (Polyamide 6.6 with 20% carbon fibre reinforcement, Tecamid 66 CF 20) for the insert and no evidence was found that it has been completed by other entities. Potential for harm exists due to the potential for device breakage which may include surgical delay and adverse tissue reaction. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/3/2015 |
