Recall Z-1300-2018— DePuy Spine, Inc.

Name: FDA recall Z-1300-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-15

Class II · Terminated

Class II FDA medical device recall by DePuy Spine, Inc., initiated 2017-12-15, terminated 2020-04-13. It names one FDA 510(k) clearance: K060300. 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: 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..

Recalling firm: DePuy Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Terminated: 2020-04-13
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060300 — CONFIDENCE HIGH VISCOSITY BONE CEMENTDisc-O-Tech Medical Technologies, Ltd.·cleared 2006-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.