Recall Z-1111-2025 ยท NHA Abutment, Implant, Dental, Endosseous
DDS Lab
Temporary Titanium Abutments
| Date | Feb 5, 2025 (initiated Dec 6, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | On 12/6/2024, correction notices were mailed to customers asking them to do the following: Patients that received a dental implant restoration processed with a temporary titanium abutment (cylinder) rather than a definitive titanium abutment should be contacted to inform them about this Correction. Dental providers should continue to monitor a restoration subject to this Correction for potential problems, consistent with their clinical standard of care for all dental implant restorations. Firm is actively collaborating with dental support organizations and dental offices to ensure patients |
| Quantity | 11,259 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc., Oct 10, 2007 |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM BioHorizons Implant Systems, Inc., Apr 2, 2010 |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER BioHorizons Implant Systems, Inc., Nov 3, 2011 |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments BioHorizons Implant Systems, Inc., Oct 13, 2023 |