FDAFebruary 23, 2018device
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
sofradim productionsofradim
UPCs
10884521532298
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPotato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPC: 7071630261742024-08-26
- FDAM&P Delicacies PIROZHKI (PIES) with CABBAGE; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: cabbage, carrot, sauerkraut, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN2024-08-26
- FDAM&P Delicacies PIROZHKI (PIES) with Black Currant; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Black currant, sugar, farina; 1 SERVING READY TO EAT; KEEP FROZEN2024-08-26
- FDAM&P Delicacies PIROZHKI (PIES) with POTATOES; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Potatoe, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN2024-08-26
- FDAFarmer Cheese Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Farmer Cheese; UPC: 7071630261812024-08-26
- FDAM&P Food Products Cheese Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk, eggs, margarine, sugar, salt; FILLING INGREDIENTS: Farmer Cheese; Cheese Blintzes; UPC: 7071633032512024-08-26
- FDAM&P Food Products Cheese & Cherry Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk; eggs, margarine; sugar, salt; FILLING INGREDIENTS: Farmer Cheese, cherries; Cheese & Cherry Blintzes Net Wt. 14 OZ. (396g) UPC: 7071633032572024-08-26
- FDASour Cherry Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Sour Cherry, Sugar; UPC: 7071630261502024-08-26
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →