Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional mon
FDA device recall Z-1523-2018 · posted 2018-04-26 · Terminated
Recall details
- Recalling firm
- Sofradim Production
- Reason for recall
- 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.
- Action taken
- All consignees were notified via Federal Express or certified mail on February 23, 2018. Customers were advised of the added warning on the product labeling. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers with questions were directed to contact their Medtronic Representative, or Customer Service at 800-962-9888, option 2.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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 : Be
- Date initiated
- 2018-02-23
- Date posted
- 2018-04-26
- Date terminated
- 2020-05-12
- Location
- Trevoux, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Versatex Monofilament Mesh (K150091) | Sofradim Production | 2015-05-26 |