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OsteoSparx C Paste
ISOTIS ORTHOBIOLOGICS, INC. · Model 56220030 · UDI-DI 10889981055752
2
510(k) clearances
185
Adverse events (1 deaths)
41
Recalls
50
Facilities
Description
OsteoSparx C Paste, 3cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
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.