Recall Z-3175-2011 ยท HRX Arthroscope
Medtronic Spine LLC (formerly Kyphon Inc.)
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.
| Date | Sep 9, 2011 (initiated Mar 23, 2011) |
| Status | Terminated |
| Reason | Device was shipped past the labeled expiration date. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 44 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |