Versatex Monofilament Mesh 50 x 50cm recall
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile.…
Why was Versatex Monofilament Mesh 50 x 50cm recalled?
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI - 10884521532298 Lots SPC1091X SPJ0706X SPJ1016X SQA0990X SQI0302X SQJ0443X SQK0319X SRA2188X SRI0548X
- Product
- Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile.…
- Recalling firm
- Sofradim Production
- Quantity
- 703
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of: CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)