Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.ġ A record in this database is created when a firm initiates a correction or removal action. Questions or assistance - contact Customer Service at 1-86. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label.ġ) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number.Ģ) Respond to the Recall email or call toll free at 1-86 to report the number of units at their location.ģ) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Patient chart label contains incorrect Part Number and volume amount. Putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY More information can be found here.Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Puttyįiller, bone void, synthetic peptide - Product Code NOX This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.Ĭerapedics is an ortho-biologics company focused on developing and commercializing its proprietary small peptide (P-15) technology platform. In the United States, i-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE," said Jeffrey Marx, Ph.D., President and Chief Operating Officer of Cerapedics.ĬAUTION: In the United States, P-15L Bone Graft (i-FACTOR+ Matrix) is an Investigational Product limited by Federal Law to investigational use only. "In addition to the commercial launch in Canada, the latest i-FACTOR+ MATRIX generation is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a U.S. Cerapedics initial P-15 technology product, i-FACTOR Peptide Enhanced Bone Graft, was approved in the European Union in 2008 and Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). I-FACTOR+ MATRIX utilizes a small proprietary peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. " Canada will be the first market offering the i-FACTOR+ MATRIX product, which leverages the clinically proven P-15 osteogenic cell-binding peptide combined with a collagen carrier for optimized handling." "We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications," said Glen Kashuba, Chief Executive Officer of Cerapedics. 5, 2020 /PRNewswire/ - Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. Canada will be the first commercial market to launch i-FACTOR ®+ Matrix
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