FDA Device recall Z-1698-2018
Straumann¿ Emdogain 0.7 ml Multipack
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Straumann¿ Emdogain 0.7 ml Multipack by Straumann Manufacturing, citing A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1698-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-23 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Straumann Manufacturing |
| Distribution | US |
Product
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Reason
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Identifiers
| code_info | Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739,…Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2018%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.