IVOCLAR VIVADENT AG: IPS e.max ZirCAD Dental Blocks Recalled Due to Risk of Cracking and Fracture

What You Should Do

1. Check your inventory for IPS e.max ZirCAD CER/in. Prime blocks in shades BL1, A1, A2, A3, B1, and C2 with specific Article Numbers: 758434, 758437, 758438, 758439, 758441, and 758443.
2. Verify if your product is affected by matching the lot or batch numbers on the packaging, specifically: Z063MW, Z067JD, Z067J5, Z067J6, Z06CBD, Z06CBF, Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N, Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG, Z065M0, Z06CBH, or Z065M1.
3. Inspect any restorations currently in production or recently completed using these lots for visible cracks immediately after the sintering process.
4. Stop using any affected blocks from these specific lot numbers and set them aside to prevent further use in patient restorations.
5. Contact your dental healthcare provider or Ivoclar Vivadent AG directly at their Liechtenstein headquarters or through US distribution channels for further instructions on returning defective product or obtaining a refund.
6. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products