Home / Recalls / NOBEL BIOCARE SERVICES AG / Z-2828-2020

Z-2828-2020 Class II Terminated

Recalled by NOBEL BIOCARE SERVICES AG — Kloten, N/A

Recall Details

Product Type: Devices
Report Date: August 26, 2020
Initiation Date: July 20, 2020
Termination Date: May 12, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 188

Product Description

NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants 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

Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.

Code Information

Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525