Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37332 |
| Brand Name: | Palacos with Gentamicin |
| Model: | For PALACOS® R+G pro 80, For PALACOS® MV+G pro 80: |
| Affected: | Catalogue number: 5081289, 5081291 |
| Software version: | |
| Recalling Organisation: | DBM Medical Limited 363c East Tamaki Road East Tamaki Auckland 2013 |
| Contact Information: | |
| Manufacturer: | Heraeus Medical GmbH |
| Brand Name: | Palacos Pro |
| Model: | For PALACOS® R+G pro 40 |
| Affected: | Catalogue number: 5081288 |
| Software version: | |
| Recalling Organisation: | Orthomed NZ Ltd 8/3 Settlers Crescent Ferrymead Christchurch 8081 |
| Contact Information: | |
| Manufacturer: | Heraeus Medical GmbH |
| Issue: | There have been isolated cases of monomer liquid leaking from the pro system. Assessments carried out to date have shown that the system can continue to be used as intended. However, if the product does leak, the system will need to be discarded and an alternate product used. If the product leaks, it cannot be entirely ruled out that users may come into contact with monomer liquid whilst handling the product. In the event of eye contact, there is a risk of temporary irritation, redness, a burning sensation or other local symptoms,which may require medical attention. Eye protection control information is already part of the PALACOS and COPAL pro safety data sheets. Nevertheless, the manufacturer has decided to expand the safety precautions as an additional layer of protection in the Instructions for Use. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/8/2026 |
