Recall Z-1111-2025— DDS Lab
Class II · Ongoing
Class II FDA medical device recall by DDS Lab, initiated 2024-12-06. It names 4 FDA 510(k) clearances: K223697, K103691, K093321 and 1 more. Product: Temporary Titanium Abutments. Reason: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated..
- Recalling firm
- DDS Lab
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-06
- Firm location
- Tampa, FL, United States
510(k) clearances named in this recall
4 on FDA's record- K223697 — MRI compatibility for existing BioHorizons dental implants and abutments
- K103691 — BIOHORIZONS ABUTMENTS FOR ZIMMER
- K093321 — BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
- K071638 — BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K-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
Temporary Titanium Abutments
Reason for recall
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.