FDA-Device2020-06-10Class II
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Nobel Biocare Usa Llc
Hazard
The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
Sold states
US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None
Affected count
221 implants
Manufactured in
22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, United States
Products
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2020Don't want to check this manually?
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