Recall Z-1845-2019— Zimmer Biomet, Inc.

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-04-01, terminated 2020-05-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery. Reason: Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw.

Recalling firm

Zimmer Biomet, Inc.

Classification

Class II

Status

Terminated

Initiated

2019-04-01

Terminated

2020-05-11

Firm location

Warsaw, IN, United States

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