Recall Z-2037-2023— Implant Direct Sybron Manufacturing LLC
Class II · Ongoing
Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2023-05-02. It names one FDA 510(k) clearance: K223535. Product: 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;. Reason: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established..
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-02
- Firm location
- Westlake Village, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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;
Reason for recall
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Data sourced from openFDA. This site is unofficial and independent of the FDA.