—#173314

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Number: 2017102450

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-04-01
Terminated: 2020-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173314. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.