FDA recall Z-2207-2020

Product

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-19

Report date

2020-06-10

Termination date

2020-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2020