KYPHON Xpander Inflatable Bone Tamp recallZ-1209-2009 · Medtronic Spine LLC, formerly Kyphon Inc · initiated Feb 4, 2009
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Spine LLC, formerly Kyphon Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product not sterile: 10 units were released for distribution without undergoing sterilization process.
FDA root cause category: Process change control
What the company is doing
Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees.
Recall details
- Recall number
- Z-1209-2009
- Status
- Terminated
- Initiated by the company
- Feb 4, 2009
- Posted by the FDA
- May 11, 2009
- Recalling firm
- Medtronic Spine LLC, formerly Kyphon Inc
- Quantity
- 10 units affected.
- Product code
- HRX
- FDA submissions
- K041454
- Distribution
- Product was distributed to two hospitals in OH and FL.
Product description
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Code information (models, lots, serial numbers)
Catalog number K09A, Lot number 50000231, UPN 00858196001161.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KYPHON Xpander™ Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE1 recall41 reports
Product lines
Other devices under the same FDA submission
36 devices cleared under K041454 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- InflateFX™ Gen II Fracture Management EL153BMedtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
- KYPHON Xpander KyphoPak Tray KPT1502Medtronic Sofamor Danek, Inc. · Arthroscope45 reports
- KYPHON Xpander Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · Arthroscope35 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · Arthroscope21 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE17 reports
- KYPHON Xpander Inflatable Bone Tamp K08AMedtronic Sofamor Danek, Inc. · Arthroscope11 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE9 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AMedtronic Sofamor Danek, Inc. · Arthroscope9 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE8 reports
- KYPHON Xpander Inflatable Bone Tamp K13AMedtronic Sofamor Danek, Inc. · Arthroscope7 reports
- KYPHON Express Inflatable Bone Tamp K15BMedtronic Sofamor Danek, Inc. · Arthroscope7 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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