Recall Z-3141-2017— Medtronic Navigation, Inc.

Name: FDA recall Z-3141-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2017-06-29, terminated 2023-07-24. It names one FDA 510(k) clearance: K131425. Product: Spine Referencing Instrumentation, Double 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.. Reason: 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Terminated: 2023-07-24
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K131425 — NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTERMedtronic Navigation, Inc.·cleared 2013-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Spine Referencing Instrumentation, Double 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.