Recall Z-2534-2016 · DZE Implant, Endosseous, Root-Form
Straumann Manufacturing, Inc.
Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
| Date | Jul 14, 2016 |
| Status | Terminated |
| Reason | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration |
| Root cause | Under Investigation by firm |
| Action | Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the |
| Quantity | 70 pieces |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants Straumann USA, LLC, Jul 24, 2015 |