Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage…
Enhancement Medical, LLC · 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 incl…
Open FDA's page for this record- Cfres ID
- 128288
- Product res number
- Z-2135-2014
- Event date initiated
- 2013-08-07
- Event date posted
- 2014-08-08
- Recall status
- Terminated
- Event date terminated
- 2017-09-29
- Res event number
- 68596
- Product code
- LMH
- Firm FEI number
- 3008404291
- Recalling firm
- Enhancement Medical, LLC
- Address 1
- 10201 Innovation Drive
- Address 2
- Suite 450
- City
- Wauwatosa
- State
- WI
- Postal code
- 53226
- Additional info contact
- Customer Service 414-918-4280
- Root cause description
- Device Design
- Product quantity
- 17,875
- Distribution pattern
- Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
- Product description
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 info
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.
- 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.
- 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.
- Harmonized identifiers (openFDA)
- Device name
- Implant, Dermal, For Aesthetic Use
- Medical specialty description
- Unknown
- Device class
- 3
- PMA number
- P250016, P850053, P170002, P020012, P040024, P140029, P050052, P030032, P020023, P250020, P240008, P070013, P050037, P160042, P240022, P050047, P800022, P110033, P250021, P090016, P050033, P030050
- Registration number
- 3048051492, 3004423487, 3006123332, 3042708459, 3015373820, 3026391021, 2135225, 3003707320, 3015471896, 3003672980, 3007772056, 3043045982, 3045078914, 3031983053, 3031056804, 9710154, 3005113652, 3002807108, 3007744205, 3005975625, 3033486016, 3004362706, 3002806738, 3010164402, 3037006441, 1000118068, 3013840437, 3019585045, 3027345797, 3043624366, 3036164410, 3009882464, 3006999111, 3022121566, 2011068
- FEI number
- 3048051492, 3004423487, 3006123332, 3042708459, 3015373820, 3026391021, 3003707320, 3015471896, 3003672980, 3007772056, 3043045982, 3045078914, 3031983053, 3003407669, 3007517952, 3031056804, 3003347293, 3002807108, 3005113652, 3007744205, 3005975625, 3033486016, 3004362706, 3002806738, 3037006441, 1000118068, 3013840437, 3019585045, 3027345797, 3043624366, 3036164410, 3009882464, 3006999111, 3022121566, 2011068