Ivoclar Vivadent Ltd - Ivoclar Vivadent Ag Dental Bonding
- Recalling firm
- Ivoclar Vivadent Ltd
- Product
- Ivoclar Vivadent Ltd - Ivoclar Vivadent AG Dental bonding. [Device]. Model: Adhese 2 DC VivaPen Kit 2ml/100 and DC Cannulas for VivaPen / 100. Affected: Lots - Z0BRVD, Z0BSTG, Z0BR7Z, Z0BRVD and Z0BKPJ, Z0BKPK, Z0BNFX, Z0BP64
- Reason
- The manufacturer has identified a potential safety risk in the Adhese 2 DC product, specifically the blue DC Cannulas. During additional, quality testing, an unexpected variation in the amount of activator on some cannulas was observed. Depending on the individual clinical situation, this amount may result in reduced bonding of the restoration to the tooth structure and a potential loss of the restoration., The problem relates exclusively to the blue DC cannulas. Therefore, the Adhese 2 product can be used without problem in light-curing mode using the black cannulas or with the single...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-26
- Status
- Ongoing
- Distribution
- New Zealand - Healthcare Professional
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8c8d4bd6-eb9d-4ffe-a629-fb5657155599