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U.S. Department of Health and Human Services

Class 1 Device Recall Enhancement Medical expression

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  Class 1 Device Recall Enhancement Medical expression see related information
Date Initiated by Firm August 07, 2013
Date Posted August 08, 2014
Recall Status1 Terminated 3 on September 29, 2017
Recall Number Z-2135-2014
Recall Event ID 68596
Product Classification Implant, dermal, for aesthetic use - Product Code LMH
Product Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml.

Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
Code Information Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203.  RECALL EXPANDED 7-8-2014 to include ALL LOTS.
Recalling Firm/
Manufacturer		 Enhancement Medical, LLC
10201 Innovation Drive
Suite 450
Wauwatosa WI 53226
For Additional Information Contact Customer Service
414-918-4280
Manufacturer Reason
for Recall		 Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.
FDA Determined
Cause 2		 Device Design
Action Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product. EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm. Customers with questions were instructed to call 414-918-4280.
Quantity in Commerce 17,875
Distribution Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
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.
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