OviTex® PRS
TELA BIO, INC. · Model R20243-1122P · UDI-DI 00856072005142
Description
The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
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