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U.S. Department of Health and Human Services

Class 2 Device Recall KyphX HVR Bone Cement

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  Class 2 Device Recall KyphX HVR Bone Cement see related information
Date Initiated by Firm November 10, 2009
Date Posted March 11, 2011
Recall Status1 Terminated 3 on March 11, 2011
Recall Number Z-1625-2011
Recall Event ID 54384
510(K)Number K033801  K041584  
Product Classification Cement, bone, vertebroplasty - Product Code JDZ
Product Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA.

Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
Code Information Lot Numbers: 0000776598, 0000790377, 0000790380, 0000794905, 0000794997, 0000794998, 0000794999, 0000795000, 0000802774, 0000802775, 0000819410, 0000825149, 0000828632, 0000828633, 0000841918, 0000841919, 0000842869, 0000842871, 0000848666, 0000848670, 0000858673, 0000892106, 000089859, 0000911555, 0000922990, 0000925894, 0000930458, 0000931993, 0000945996, 0000952887, 0000958800, 00009666732, 0000966734, 0000972324, 0000972325, 0000975787, 0000982884, 0000994176, 0001008470, 0001008472, 0001008598, 0001033988, 0001034877, 0001045184, 0001045187, 0001050788, 0001050789, 0001056101, 0001056102, 0001060659, 0001060662, 0001067884, 0001067886, 0001081545, 0001104034, 00841918, 88930458, J6092716, J6100426, J6101208, J6101808, J6103009, J6110310, J6110906, J6112008, J6112712, J6120108, J6121203, J6121902, J6121903, J6121904, J6121905, J6121906, J7010201, J7011107, J7011907, J7012506, J7020624, J7021509, J7022202, J7022702, J7030605, J7031401, J7031506, J7032310, J7032702, J7040213, J7041010, J7041301, J7042109, J7050101, J7050405, J7051107, J7051801, J7052511, J7060205, J7061130, J7062109, J7062708, J7070210, J7070706, J7071602, J7071906, J7072702, J7080702, J7081815, J7081816, J7082816, J7090620, J7091106, J7091208, J7091206, J7100606, J7101704, J7101705, J7110523, J7111216, J7111608, J7112823, J7120314, J7122101, J8010201, J8010402, J8010918, J8010718, J8041401, J8041705, J8042401, J8051203, J8051204, J8052915, J8052916, J8060205, J8060410, J8061208, J8010919, J8012214, J8013005, J8020117, J8020722, J8021910, J8030517, J8030518, J8031202, J8032601, J8040717, J8061209
Recalling Firm/
Manufacturer		 Medtronic Spine LLC, formerly Kyphon Inc
1221 Crossman Ave
Sunnyvale CA 94089-1103
For Additional Information Contact
408-548-6740
Manufacturer Reason
for Recall		 Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.
FDA Determined
Cause 2		 Other
Action The firm, Medtronic Spine LLC, sent an "URGENT DEVICE RECALL NOTICE" dated November 9, 2009 to the customers. The notice described the product, problem and actions to be taken. The customers were instructed to return the affected lots to Medtronic Spine; to not use any of the affected product that they may have received (Medtronic will replace any affected product in their inventory), the customer should contact their Medtronic Spine sales representative or customer service at [866-959-7466 or for geography] for assistance with replacement product, and complete and return the URGENT DEVICE RECALL NOTICE: Action Required form to Medtronic Spine LLC via fax at (408) 543-6192 or mail to: Medtronic Spine LLC, Attn: Recall Coordinator, 1221 Crossman Avenue, Sunnyvale, CA 94089. If you have any questions about this notification, please do not hesitate to contact Sr. Director, Regulatory Affairs via email: pamela.n.segale@medtronic.com or phone at (408) 548-5235.
Distribution USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDZ and Original Applicant = KYPHON, INC.
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