Z-1750-2018 Class II Terminated
FDA device recall Z-1750-2018 was initiated by Medtronic Sofamor Danek USA Inc on Mar 23, 2018 and is designated Class II. Reason for recall: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. The recall status is terminated (terminated Jul 25, 2021). Affected quantity: 39 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 23, 2018
- Termination Date
- Jul 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product Description
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
Reason for Recall
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Code Information
GTIN/UPN: 643169329218 Lot Number: H5399679
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1750-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026