FDA-Device2020-06-10Class II
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.
Nobel Biocare Usa Llc
Hazard
Packaged dental implant healing abutments were found to contain the wrong size device.
Sold states
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.
Affected count
234 pieces globally, of which 16 were sent to the US.
Manufactured in
22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2020Don't want to check this manually?
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