Z-3139-2017Class II

Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation...

Name: Z-3139-2017 Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation...
Creator: Medtronic Navigation, Inc.
Published: 2017-06-29
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2017-06-29 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation... on 2017-06-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3139-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2017-09-21
Terminated: 2023-07-24
Recalling firm: Medtronic Navigation, Inc
Product: Spine Referencing Instrumentation, Spinous Process Clamp, Tall 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.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic sent an Urgent Medical Device Correction letter dated June 27, 2017, to all affected consignees. The letter notifies consignees of the product correction and requests that practitioners follow the attached use instructions for devices. Practitioners are to identify product damage before each procedure by opening and closing the device jaw with the T-handle. It is instructed that practitioners not continue turning the screw if resistance is met, as this may break the washer. Clamps are not to be used if the jaws remain closed when attempting to open a clamp or if the clamp screw back is out of the clamp. It is asked that this check is done to all inventory and any damaged product is to be reported to Medtronic at 1-800-595-9709 and quarantined. Revised product is available. Consignees are asked to complete and return the provided Consignee Response Form by email to the firm at [email protected] or by fax to 651-367-7075. Any questions can be directed to 1-800-595-9709.
Quantity in commerce: 2,051 units total
Distribution: 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.
Product codes and lots: P/N 9734715, 9734715K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3139-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3139-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-21
Z-3140-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-21
Z-3141-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-21
Z-3142-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-21
Z-3143-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-21

Product code OLO

K131425Class IINavigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. / cleared 2013-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)