Data Foundry

Medical device recalls 2018

Medtronic ZEVO — Class II medical device recall Z-1750-2018

Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2018-05-16, distributed nationwide. Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length o

Recall numberZ-1750-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedtronic Sofamor Danek USA Inc, Memphis, TN, United States
Recall initiated2018-03-23
Classified2018-05-08
Reported by FDA2018-05-16
Terminated2021-07-25
DistributedNationwide (US)
Countries outside the USFR
Quantity39 units
UPC / GTIN / UDI-DI00643169329218
Lot numbersH5399679
Model numbers7710015

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1750-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.