Salvin OraMem®
Integra Lifesciences Corporation · Model #ORAMEMSUS15X20 · UDI-DI 10381780072607
Description
#ORAMEM SUS 15x20 OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-16 | Collagen Matrix, Inc. | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only |
| 2016-09-07 | Osteogenics Biomedical, Inc. | The device has the potential to be packaged in the wrong product box. |
| 2016-01-21 | Biomet France SARL | Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury. |
| 2013-10-03 | Biomet 3i, LLC | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number. |
| 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. |
| 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. |
| 2012-10-25 | Kerr Corporation | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. |
| 2012-01-11 | Cytophil, Inc | Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an in |
| 2010-05-14 | Ace Surgical Supply Co., Inc. | Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risk |
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