# FDA recall Z-1845-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-04-01.

## 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 for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1845-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-01
- **Report date:** 2019-06-26
- **Termination date:** 2020-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2019

## Citation

> AI Analytics. FDA recall Z-1845-2019. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1845-2019. Source: US FDA. Licensed CC0.

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