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Straumann Xenograft
Nibec Co., Ltd. · Model S1-0210-050 · UDI-DI 08809186548847
NPM
Prescription
1
510(k) clearances
113
Adverse events
11
Recalls
47
Facilities
Description
Straumann Xenograft bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. Straumann Xenograft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Straumann Xenograft is effective for the regeneration of new bone around the grafted bone. Straumann Xenograft has good osteoconductivity to enhance new bone formation.
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.