FDA recall Z-1300-2018

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).

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

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

Key facts

Status

Terminated

Initiation date

2017-12-15

Report date

2018-04-11

Termination date

2020-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2018