Recall Z-1851-2020 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
| Date | May 4, 2020 (initiated Aug 28, 2019) |
| Status | Terminated |
| Reason | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm). |
| Root cause | Labeling mix-ups |
| Action | The firm's "Urgent Field Safety Notice", was issued on 08/28/2019 and the notices were sent to customers via email . The following actions are to be taken: 1) Identify affected devices in stock by confirming the information on the side label: 3.75x10mm, article no. 37965, lot 12129104. 2) Confirm that both the side and top label indicate 3.75x10mm. 3) Complete a Customer Acknowledgment Form and return it via email to: cs.russia@nobelbiocare.com within 5 days of receipt of the notice. 4) Return incorrectly labeled products (top label 3.75x7mm) to: Attn: Returns PFA1925 109004 Moscow Stanisla |
| Quantity | 228 pieces |
| Distribution | International distribution - the country Russia only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173418 | NobelParallel Conical Connection Nobel Biocare AB, Feb 21, 2019 |