Kloten, N/A, Switzerland
NOBEL BIOCARE SERVICES AG recalls
1 recall recorded since 2018, most recently on 20 July 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 July 2020
- Terminated
- 12 May 2021
- Reason
- 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
- Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2828-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.