DDS Lab recalls Temporary Titanium Abutments

Recall date

December 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1111-2025

FDA classification

Class II

Brand / firm

DDS Lab

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Temporary Titanium Abutments