Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Pro
FDA device recall Z-3175-2011 · posted 2011-09-09 · Terminated
Recall details
- Recalling firm
- Medtronic Spine LLC (formerly Kyphon Inc.)
- Reason for recall
- Device was shipped past the labeled expiration date.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 44
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-03-23
- Date posted
- 2011-09-09
- Date terminated
- 2011-09-09
- Location
- Sunnyvale, CA
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