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Terminated

Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement 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: CO1A; 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.

FDA Recall Z-1624-2011 · Posted 2011-03-11

Recalling FirmMedtronic Spine LLC, formerly Kyphon Inc
Recall StatusTerminated
Product CodeNDN
Date Initiated2009-11-10
Date Terminated2011-03-11

Reason for Recall

Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041584KYPHX HV-R BONE CEMENT, MODEL C01AKyphon, Inc. · 2004-07-07K033801KYPHX HV-R, MODEL C01AKyphon, Inc. · 2004-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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