Recall Z-2250-2020 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
| Date | May 28, 2019 |
| Status | Terminated |
| Reason | Packaged dental implant healing abutments were found to contain the wrong size device. |
| Root cause | Labeling mix-ups |
| Action | On 5/28/2019, the firm mailed "Urgent Medical Device Recall" letters with an acknowledgement forms. The letter instructs the customers to: 1. Identify affected devices in your stock. 2. Do not use affected devices. 3. Complete and return the Customer Acknowledgment Form. 4. Return affected devices. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x 1527. |
| Quantity | 234 pieces globally, of which 16 were sent to the US. |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT Nobel Biocare AB, Aug 3, 2007 |