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OviTex® PRS
TELA BIO, INC. · Model R20153-2020G · UDI-DI 00856072005111
10
510(k) clearances
11,594
Adverse events (47 deaths)
76
Recalls
89
Facilities
Description
OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.