Recall Z-0314-2027— Stryker Leibinger GmbH & Co. KG

Name: FDA recall Z-0314-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-24

Class II · Ongoing

Class II FDA medical device recall by Stryker Leibinger GmbH & Co. KG, initiated 2026-09-24. It names one FDA 510(k) clearance: K212194. Product: Precision Pointer Electromagnetic (8000-050-001). Reason: Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient..

Recalling firm: Stryker Leibinger GmbH & Co. KG
Classification: Class II
Status: Ongoing
Initiated: 2026-09-24
Firm location: Freiburg Im Breisgau, Germany

510(k) clearances named in this recall

1 on FDA's record

K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting SystemStryker Corporation·cleared 2023-02-16

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

Precision Pointer Electromagnetic (8000-050-001)

Reason for recall

Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.

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