Recall Z-0924-2020 ยท EJL Bur, Dental
Jjgc Industria E Comercio De Materials Dentarios Sa
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
| Date | Jan 30, 2020 (initiated Dec 23, 2019) |
| Status | Terminated |
| Reason | The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill". |
| Root cause | Under Investigation by firm |
| Action | Customers were notified of the recall on 12/23/2019 via telephone and email. Customers were instructed to do the following: - If the clinician has already used the drill for osteotomy and successfully concluded the installation of the implant, additional patient follow-up not required. The implant will behave as normally expected. - Identify and segregate the affected units, opened or unopened, in your stock. - If the product is still in your inventory, return it to the attention of "Action 0002/2019 Product Removal" for credit as indicated on ANNEX 1: Customer Confirmation Form. - If the p |
| Quantity | 2 |
| Distribution | Distributed to consignees in CA and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.