Nobel Biocare Usa Llc: Medical Device Recall in 2020 - (Recall #: Z-2207-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 19, 2019

Date Posted: June 10, 2020

Recall Number: Z-2207-2020

Event ID: 85331

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.

Status: Terminated

Product Quantity: 221 implants

Code Information:

Lot number: 13080792

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated