Device recall: Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance…

Class II FDA enforcement event 79792. Recall start date: 23 Mar 2018. Status in the FDA record: Terminated. Termination date: 25 Jul 2021.

Reason for recall, in the words of FDA

Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Medtronic Sofamor Danek USA Inc started this device recall on 23 Mar 2018. The firm address in the FDA record is in Memphis, TN. FDA put the recall in Class II. FDA event 79792 has 1 product record. The first FDA enforcement report date is 16 May 2018. The record gives the status Terminated, with the termination date 25 Jul 2021.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Recalling firm

Medtronic Sofamor Danek USA Inc, Memphis, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79792: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1750-2018	Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body	39 units	Class II	Terminated	16 May 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 31

Other events of the firm

Other FDA enforcement events of Medtronic Sofamor Danek USA Inc
Initiated	Product (first record)	Type	Class	Records
16 Sep 2025	Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CA	Device	Class II	1
26 Sep 2023	Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix	Device	Class II	7
31 Jul 2023	Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.	Device	Class II	1
12 Jul 2023	CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K	Device	Class II	1
6 Jun 2023	Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant	Device	Class II	7
16 Feb 2023	INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization	Device	Class II	5
8 Feb 2023	Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c)	Device	Class II	12
19 Nov 2021	Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in sp	Device	Class II	1
2 Sep 2021	Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm	Device	Class II	2
27 Apr 2021	Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spina	Device	Class II	1

Medtronic Sofamor Danek USA Inc: all 31 events

Official channels

FDA enforcement report Z-1750-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79792. https://recallregister.com/fda/ii/79792/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
What quantity of product is in FDA event 79792?: The FDA record gives this quantity: 39 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.