FDAFDA · Food and drugs·Recall number Z-1851-2020
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.
Published May 13, 2020 · Recall initiated: August 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nobel Biocare Usa Llc
- Distributor
- International distribution - the country Russia only.
- Lot
- Lot:12129104
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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