Straumann¿ Emdogain 0 — Class II medical device recall Z-1696-2018
Terminated recall by Straumann Manufacturing, Inc., reported 2018-05-16, distributed nationwide. A change regarding the shelf life of a raw material was implemented without an appropriate submission of data
| Recall number | Z-1696-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann Manufacturing, Inc., Andover, MA, United States |
| Recall initiated | 2018-03-23 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,915 |
| Lot numbers | MN843, NE101A, NK216, NP738, NY938, PG629, PT888C, PY817 |
| Expiration dates | 2018-11-30, 2019-03-31, 2019-05-31, 2020-01-31 |
Product
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1696-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.