Straumann USA LLC: GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Hazard

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

Details from the source

Reason for recall: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Quantity: 417 US Lot/code info: UDI-DI 7899878024552 Lot MVXJ9

UPC codes

7899878024552

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.