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3D Dental- Bioviva
3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Model SPG592 · UDI-DI 00817169021599
GAL
Prescription
10
510(k) clearances
2,498
Adverse events (5 deaths)
5
Recalls
70
Facilities
Description
BIOVIVA SUTURE PLAIN GUT C-6 3/0 18"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-01 | Covidien, LP | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec |
| 2023-03-01 | Covidien, LP | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec |
| 2023-03-01 | Covidien, LP | Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec |
| 2019-02-04 | CP Medical Inc | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. |
| 2015-05-08 | Ethicon, Inc. | Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. |
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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.