CLASS II ONGOING Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

Mazor X Surgical System Positioner Type II recalled

Medtronic Navigation is recalling Mazor X Surgical System Positioner Type II, distributed in 28 states. The recall was initiated on 5 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled177 Systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2330-2020
FDA event ID: 85387
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Ongoing
Recall initiated: 5 Dec 2019
FDA classified: 9 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

5 Dec 2019	Recall initiated by company
9 Jun 2020	Classified by FDA	+187 days
17 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

Product as listed by the FDA

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

Where it was distributed

US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,

Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kentucky Massachusetts Michigan Minnesota Missouri North Carolina North Dakota New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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