Some members have been made aware of a situation regarding certain Ethicon/Gynecare products. As a service to our members, we are distributing the following message from Ethicon to explain the situation:
The U.S. FDA recently reclassified the manual surgical instruments (Helical Passers and Winged Guide) utilized for the Gynecare TVT Abbrevo and TVT Obturator from Class I to Class II. Accordingly, Ethicon is now required to obtain a 510(k) clearance to distribute and market these instruments. Ethicon has filed a 510(k) submission and it is currently under review by FDA. FDA has requested Ethicon cease distribution and marketing of these instruments until our 510(k) is cleared by FDA. The FDA reclassification relates to the manual surgical instruments (Helical Passers and Winged Guide) utilized for the Gynecare TVT Abbrevo and TVT Obturator and does not relate to the mesh implant.
This stop shipment impacts the United States only, as the reclassification is from U.S. FDA. This stop shipment is for TVT Abbrevo and TVT Obturator product codes:
- 810081 GYNECARE TVT OBTURATOR -SYSTEM
- 810081L GYNECARE TVT OBTURATOR W LASR -CUT MESH
- TVTOML GYNECARE TVT-ABBREVO LASER CUT DISPOSABLE SYSTEM
- TVTOML6 TVT-ABBREVO 6 PACK
- TVTO6 TVTO6
- TVTMIX6 COMBINATION 6 PACK TVT-EXACT (3) AND TVT-ABBREVO (3)
- TVTOML5 TVT ABBREVO 5-PACK PROMOTION
The stop shipment impacts only the codes listed above – all remaining TVT codes are not subject to the stop shipment. Customers are not required to return current product in their inventory. Our timeline to return to the market will be contingent upon the FDA’s review.