Z-1845-2019Class II

Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item...

Name: Z-1845-2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item...
Creator: Zimmer Biomet, Inc.
Published: 2019-04-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-04-01 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC... on 2019-04-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1845-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Posted: 2019-06-19
Terminated: 2020-05-11
Recalling firm: Zimmer GmbH
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
Product code: LXH Orthopedic Manual Surgical Instrument
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
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Zimmer issued letter notification dated 4/1/19 via email and FedX identifying the issue, health risk, and action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2.Immediately locate and quarantine affected product in your inventory.3.Immediately return all affected product from your distributorship and from affected hospitals within your territory. Complete Attachment 1 Inventory Return Certification Form4. Return the Additional Accounts form to [email protected]. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 313 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: 2017102450

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1845-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)