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Rebuilder Nerve Guidance Conduit
Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. · Model TG-015 · UDI-DI 06975222390007
1
510(k) clearances
165
Adverse events
4
Recalls
38
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-27 | Baxter Healthcare Corporation | The product is brittle and potentially crumbling upon handling or when being removed from its package. |
| 2020-02-07 | Integra LifeSciences Corp. | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
| 2013-03-28 | Integra LifeSciences Corporation | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. |
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