Medical Device Recall: Temporary Titanium Abutments
DDS Lab · December 6, 2024
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.
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.
States Affected
NATIONWIDE
Quantity Affected
11,259
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1111-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.