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.
Recall
- Recall Number
- Z-3175-2011
- Event Number
- 58425
- Firm
- Medtronic Spine LLC (formerly Kyphon Inc.)
- FEI Number
- 3004904811
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 23, 2011
- Posted
- September 9, 2011
- Terminated
- September 9, 2011
- Address
- 1221 Crossman Ave, Sunnyvale, CA, 94089-1103
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.
Device was shipped past the labeled expiration date.
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.
Nationwide Distribution
44