Kyphon brand KyphoPak Express Tray First Fracture, 15/2… recallZ-3175-2011 · Medtronic Spine LLC (formerly Kyphon Inc.) · initiated Mar 23, 2011
Terminated All recalls posted in September 2011
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
Device was shipped past the labeled expiration date.
FDA root cause category: Employee error
What the company is doing
On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.
Recall details
- Recall number
- Z-3175-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 23, 2011
- Posted by the FDA
- Sep 9, 2011
- Recalling firm
- Medtronic Spine LLC (formerly Kyphon Inc.)
- Quantity
- 44
- Product code
- HRX
- FDA submissions
- K011811, K041454
- Distribution
- Nationwide Distribution
Product description
Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
Code information (models, lots, serial numbers)
Lot Number: 0001653390
Other devices under the same FDA submission
37 devices cleared under K011811, K041454 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- KYPHON Xpander™ Inflatable Bone Tamp K09AMedtronic Sofamor Danek, Inc. · ARTHROSCOPE1 recall41 reports
- 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
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 18, 2026. Text above is shown as published by the FDA.
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