Device product

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.

Z-1851-2020

August 28, 2019

Class II

Product summary

Firm: Nobel Biocare Usa Llc
Event: Event 85236
Status: Terminated
Classification: Class II
Quantity: 228 pieces
Official record key: device-enforcement:Z-1851-2020

Official wording

Reason: 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).

Code information: Lot:12129104

Distribution pattern: International distribution - the country Russia only.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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).