FDA Enforcement
Class II
Terminated
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.
Recall: Z-2250-2020
·
Reported June 10, 2020
Enforcement
- Recall Number
- Z-2250-2020
- Event ID
- 85530
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nobel Biocare Usa Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2020
- Initiation Date
- May 28, 2019
- Classification Date
- June 3, 2020
- Termination Date
- February 9, 2021
- Address
- 22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887-4609, United States
Description
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.
Reason
Packaged dental implant healing abutments were found to contain the wrong size device.
Code Info
Lot 13076845
Distribution
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.
Quantity
234 pieces globally, of which 16 were sent to the US.