Recall Z-2037-2023 ยท NHA Abutment, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing LLC
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
| Date | Jun 29, 2023 (initiated May 2, 2023) |
| Status | Open, Classified |
| Reason | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. |
| Root cause | No Marketing Application |
| Action | On 5/2/23, correction notices were emailed to customers who were asked to do the following: 1) Contact recalling firm to arrange return of affected product that has not yet been placed in the patient. 2) Share this notice with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. 3) Complete and return the acknowledgement form to Questions, complaints, or adverse events can be reported to the recalling firm via phone 1-888-649-6425 (Monday - Friday, 5AM - 5PM PST) or through their website: https://www.implantdi |
| Quantity | 29 |
| Distribution | US Nationwide distribution in the states of FL, ID, TX, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223535 | SMARTbase Abutment System Implant Direct Sybron Manufacturing, LLC, Jun 20, 2023 |