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Accell Evo3 Putty
ISOTIS ORTHOBIOLOGICS, INC. · Model 02-5000-025 · UDI-DI 10889981055394
2
510(k) clearances
185
Adverse events (1 deaths)
41
Recalls
50
Facilities
Description
Accell Evo3 Putty, 2.5cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-02-08 | Medtronic Sofamor Danek USA Inc | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| 2023-02-08 | Medtronic Sofamor Danek USA Inc | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| 2023-02-08 | Medtronic Sofamor Danek USA Inc | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
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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.