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Straumann XenoFlex
Nibec Co., Ltd. · Model NI-0110-050 · UDI-DI 08809186541787
NPM
Prescription
1
510(k) clearances
113
Adverse events
11
Recalls
47
Facilities
Description
Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Straumann Xenograft®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-02 | Ace Surgical Supply Co., Inc. | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2018-10-30 | Collagen Matrix Inc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. |
| 2015-11-17 | Collagen Matrix Inc | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. |
| 2015-08-25 | Collagen Matrix Inc | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. |
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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.