CLASS II Device recall · Reported 27 Sep 2017 · FDA Enforcement Report

Spine Referencing Instrumentation recalled by Medtronic Navigation

Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a, distributed in 44 states. The recall was initiated on 29 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesP/N 9734724, 9734724K

Quantity recalled2,051 units total

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-3142-2017
FDA event ID: 77894
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2017
FDA classified: 21 Sep 2017
Reported: 27 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

29 Jun 2017	Recall initiated by company
21 Sep 2017	Classified by FDA	+84 days
27 Sep 2017	Published in enforcement report	+6 days

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

Reason for recall

Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.

Where it was distributed

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Is Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a recalled?

Yes. Medtronic Navigation recalled Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a on 29 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3142-2017.

Why was it recalled?

Which lots are affected?

P/N 9734724, 9734724K

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

More recalls from Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Sterility	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 3.0 and 3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide