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Recall Observatory FDA recall evidence

Device 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.

Z-2135-2014

August 07, 2013

Class I

Product summary

Firm
Enhancement Medical, LLC
Event
Event 68596
Status
Terminated
Classification
Class I
Quantity
17,875
Official record key
device-enforcement:Z-2135-2014

Official wording

Reason: 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.

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.

Distribution pattern: Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.