Recall Z-2207-2020 ยท NHA Abutment, Implant, Dental, Endosseous
Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery. |
| Root cause | Labeling mix-ups |
| Action | Customers who received product/affected lot were to be contacted via Urgent Medical Device Recall Letter dated July 18, 2019 via USPS on July 19, 2019. In addition to informing customers about the recall, the recall notification asked customer to take the following actions: 1. Identify affected devices in your stock by confirming the information on the side label: NobelActive Internal NP 3.5x15mm, article 34128, lot 13080792. 2. Confirm the information on the top label as shown in figure 1 above. 3. Complete attached Customer Acknowledgment Form and return it to Nobel Biocare, via email to us |
| Quantity | 221 implants |
| Distribution | US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT Nobel Biocare AB, Aug 3, 2007 |