Home / Recalls / Nobel Biocare Usa Llc / Z-1851-2020

Z-1851-2020 Class II Terminated

Recalled by Nobel Biocare Usa Llc — Yorba Linda, CA

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
August 28, 2019
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
228 pieces

Product Description

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

Reason for Recall

The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

Distribution Pattern

International distribution - the country Russia only.

Code Information

Lot:12129104

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