Recall Z-1022-2025— Medtronic Navigation, Inc.

Name: FDA recall Z-1022-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-04

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2024-12-04. It names one FDA 510(k) clearance: K131425. Product: Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.. Reason: Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-04
Firm location: Lafayette, 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

Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.

Reason for recall

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

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