FDA Device recall Z-1100-2022
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a repr…
- FDA Device
- Class II
- terminated
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a repr… by Clinician S Choice Dental Products, citing wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1100-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-18 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clinician S Choice Dental Products |
| Distribution | SC |
Product
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Reason
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Identifiers
| code_info | LOT No.: 611612 (UDI): 07540172000178 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.