Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19412 |
| Brand Name: | Biomet 3i Provide Protection Caps |
| Model: | PPC484, PPC654, PPC655 |
| Affected: | PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, PAK6455 |
| Software version: | |
| Recalling Organisation: | ZimVie Australia Pty Ltd (NZ) 16 Huapai Street Onehunga Auckland 1061 |
| Contact Information: | 0508 122 221 |
| Manufacturer: | Implant Innovations Inc |
| Issue: | During a review of the Provide® dental restorative product's design history file, inadequate biocompatibility testing was discovered for the Provide Protection Caps (single-use, non-implantable, temporary devices). Subsequent testing was performed and the results indicated a cytotoxic response. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 20/11/2015 |
