Z-1625-2011

Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a...

Name: Z-1625-2011 Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a...
Creator: Medtronic Spine LLC, formerly Kyphon Inc
Published: 2009-11-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-11-10 / Terminated

FDA source

Medtronic Spine LLC, formerly Kyphon Inc began a recall of 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... on 2009-11-10. The reason FDA records is "Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1625-2011
Status: Terminated
Initiated: 2009-11-10
Posted: 2011-03-11
Terminated: 2011-03-11
Recalling firm: Medtronic, Inc.
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.
Product code: JDZ Mixer, Cement, For Clinical Use
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 root cause: 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: [email protected] 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.
Product codes and lots: 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

Product code JDZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)