Z-1300-2018Class II

Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000...

Name: Z-1300-2018 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000...
Creator: DePuy Spine, Inc.
Published: 2017-12-15
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2017-12-15 / Terminated / root cause: manufacturing process

FDA source

DePuy Spine, Inc. began a recall of Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL... on 2017-12-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1300-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-04-03
Terminated: 2020-04-13
Recalling firm: DePuy Spine, Inc.
Product: 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).
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]).
Quantity in commerce: 1972
Distribution: International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
Product codes and lots: Lot numbers: 129385 129386 133824 133825 133826 133827 133828 133829 133830 133831 134609 134610 134611 134612 134613 134614 135476 135477 135478 145664 145665 145666 145667 145668 145669 145670 145671 147555 152905 152906 152908 153880 153881 153882 153883 153884 153885 153886 153888 153889 154956 154957 HVKBHH HVKBHJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code NDN

K060300Class IIConfidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. / cleared 2006-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)