Z-1845-2019 Class II Terminated
FDA device recall Z-1845-2019 was initiated by Zimmer Biomet, Inc. on April 1, 2019 and is designated Class II. 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 The recall status is terminated (terminated May 11, 2020). Affected quantity: 313 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 313 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Lot Number: 2017102450