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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Emdogain

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  Class 2 Device Recall Straumann Emdogain see related information
Date Initiated by Firm March 23, 2018
Create Date May 04, 2018
Recall Status1 Terminated 3 on May 02, 2019
Recall Number Z-1696-2018
Recall Event ID 79738
PMA Number P930021 
Product Classification Biologic material, dental - Product Code NQA
Product Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Code Information Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
Recalling Firm/
Manufacturer		 Straumann Manufacturing, Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact Jennifer M. Jackson
978-747-2509
Manufacturer 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.
FDA Determined
Cause 2		 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 Customer Confirmation Form. 3. If you have already used the Emdogain with the above listed article and lot numbers, please document receipt of this Field Safety Notice in the applicable patient files. Complete and return the enclosed Customer Confirmation Form via fax to the number listed on the form. Please also report the outcome of the surgical treatment with this product on the enclosed Customer Treatment Outcome Form and fax the form to the number listed on the form. 4. For all cases complete and return the enclosed Customer Confirmation Form and return to Straumann using the enclosed UPS label (if returning product) or via fax (if notifying us the product has already been used). This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. Updated Notification letters including an additional lot number were distributed beginning 4/18/18.
Quantity in Commerce 2915
Distribution Distributed US Nationwide and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NQA and Original Applicant = THE STRAUMANN COMPANY
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