Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
Recall
- Recall Number
- Z-1300-2018
- Event Number
- 79494
- Firm
- DePuy Spine, Inc.
- FEI Number
- 1526439
- Product Code
- NDN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 15, 2017
- Terminated
- April 13, 2020
- Address
- 325 Paramount Dr, Raynham, MA, 02767-5199
Description
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The notification described the product, problem and actions to be taken. Notifications were sent to consignees with the following instructions: 1. Immediately identify and quarantine all unused products listed below in a manner that ensures the affected products will not be used. 2. Review, complete, sign and return the attached Business Reply Form to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return any affected product within 30 business days. A credit note will be issued for the returned items. 4. Forward this notice to anyone in your facility that needs to be informed. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. 6. Maintain awareness of this notice until all products listed below have been returned to DePuy Spine. 7. Keep a copy of this notice. If you have questions about this Field Safety Notification, please contact your DePuy Synthes Spine Sales Consultant or the Recall Coordinator via telephone: 1-508-828-6609 or via email: [email protected]).
International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
1972