Home / Recalls / DePuy Spine, Inc. / Z-1300-2018

Z-1300-2018 Class II Terminated

Recalled by DePuy Spine, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
December 15, 2017
Termination Date
April 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1972

Product 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).

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.

Distribution Pattern

International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.

Code Information

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

Other recalls by DePuy Spine, Inc.

  • Z-1323-2022 Class II — EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated (May 20, 2022)
  • Z-1324-2022 Class II — EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated (May 20, 2022)
  • Z-1225-2019 Class II — Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (1 (April 8, 2019)
  • Z-1226-2019 Class II — Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (April 8, 2019)
  • Z-0628-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 (October 12, 2016)
  • Z-0625-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW (October 12, 2016)
  • Z-0624-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW (October 12, 2016)
  • Z-0626-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4 (October 12, 2016)
  • Z-0627-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW (October 12, 2016)
  • Z-0630-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4 (October 12, 2016)