DDS Lab: Device Recall
Recall #Z-1111-2025 · 12/06/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1111-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DDS Lab
- Status
- Ongoing
- Date Initiated
- 12/06/2024
- Location
- Tampa, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,259
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.
Product Description
Temporary Titanium Abutments
Distribution Pattern
US Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT, ME, WA, IN, CA, PA, NV, MO, IL, AK, MN, VT, OH, MI, VA, WI, AL, AZ, KY, MT, OK, CO, LA, GA, NY, WV, NC, NJ, MD, OR, DE, SC, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.