FDA Device recall Z-2250-2020
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended… by Nobel Biocare Usa, citing packaged dental implant healing abutments were found to contain the wrong size device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nobel Biocare Usa |
| Distribution | US |
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.
Reason
Packaged dental implant healing abutments were found to contain the wrong size device.
Identifiers
| code_info | Lot 13076845 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2020%22
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