LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW N
FDA device recall Z-2037-2023 · posted 2023-06-29 · Open, Classified
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Reason for recall
- Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
- Action taken
- 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.implantdirect.com/en-us
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 29
- Distribution
- US Nationwide distribution in the states of FL, ID, TX, CA.
- Date initiated
- 2023-05-02
- Date posted
- 2023-06-29
- Location
- Westlake Village, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMARTbase Abutment System (K223535) | Implant Direct Sybron Manufacturing, LLC | 2023-06-20 |