[pending] SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-
Pending LLM rewrite. Source: FDA_DEVICE Z-1985-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential presence of residual adhesive material on the mesh surface.
The recalled product
- Product
- SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
- Manufacturer
- Chamberlain Technologies LLC
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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