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;
FDA Recall Z-2037-2023 · Posted 2023-06-29
Advertisement
Recalling FirmImplant Direct Sybron Manufacturing LLC
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2023-05-02
Product Quantity29
Reason for Recall
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Firm 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.implantdirect.com/en-us
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distribution in the states of FL, ID, TX, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement