FDA recall Z-2318-2024

Product

9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Reason for recall

Due to incorrect milled titanium abutment being packaged and labeled.

Distribution

U.S.: CA, MO, and NV. O.U.S.: None

Key facts

Status

Ongoing

Initiation date

2024-04-10

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2318-2024