Recall Z-2207-2020— Nobel Biocare Usa Llc

Name: FDA recall Z-2207-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-07-19, terminated 2020-10-27. It names one FDA 510(k) clearance: K071370. Product: NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619. Reason: 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..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Terminated: 2020-10-27
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071370 — NOBELACTIVE INTERNAL CONNECTION IMPLANTNobel Biocare AB·cleared 2007-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.