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.
Z-2250-2020
Product summary
- Event
- Event 85530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 234 pieces globally, of which 16 were sent to the US.
- Official record key
device-enforcement:Z-2250-2020
Official wording
Reason: Packaged dental implant healing abutments were found to contain the wrong size device.
Code information: Lot 13076845
Distribution pattern: 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.
Derived failure modes
-
Unknown
Packaged dental implant healing abutments were found to contain the wrong size device.