Nobel Biocare Usa Llc recalls Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abut

Recalled June 10, 2020 · FDA recall Z-2250-2020 · Nobel Biocare Usa

Hazard

Packaged dental implant healing abutments were found to contain the wrong size device. · FDA Class II

Units

234 pieces globally, of which 16 were sent to the US.

Sold at

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.

Description

Packaged dental implant healing abutments were found to contain the wrong size device.

Product

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Manufacturer(s)

Nobel Biocare Usa Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →