Recall Z-1693-2018 ยท NQA Biologic Material, Dental
Straumann Manufacturing, Inc.
Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
| Date | Mar 23, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | Customer notification letters were distributed 3/23/18. Action to be taken: 1. Check your inventory for the above listed article and lot numbers and return all unused/unpackaged Emdogain using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. Your account will be credited upon receipt. 2. If you have already unpacked the Emdogain from the outer box, the lot number on the blister package will be different. Please check your Emdogain for the syringe blister lot numbers listed above and return them for credit using the enclosed prepaid UPS label as indicated on the |
| Quantity | 2381 |
| Distribution | Distributed US Nationwide and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.