Recall Z-2828-2020 ยท DZE Implant, Endosseous, Root-Form
NOBEL BIOCARE SERVICES AG
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants 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 | Jul 20, 2020 |
| Status | Terminated |
| Reason | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal. |
| Root cause | Process control |
| Action | On 07/20/20, Urgent Medical Device Recall notices were emailed to customers who were asked to do the following: 1. Inspect your stock and confirm that both the cap label and the vial label indicate 4.3x10mm. 2. Quarantine devices with cap label 5.0x8mm. 3. Complete attached Customer Acknowledgment Form, even if you do not have any affected stock, and return it to the recalling firm via email. 4. Return all incorrectly labeled devices to the firm. Correctly labeled devices do not need to be returned. 5. Ensure relevant staff members are informed of this recall. If you have supplied or transfer |
| Quantity | 188 |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT Nobel Biocare USA, LLC, Jan 11, 2008 |