Z-0314-2027

Precision Pointer Electromagnetic (8000-050-001)

Name: Z-0314-2027 Precision Pointer Electromagnetic (8000-050-001)
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2026-09-24
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2026-09-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0314-2027
Status: Open, Classified
Initiated: 2026-09-24
Posted: 2026-10-29
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: Precision Pointer Electromagnetic (8000-050-001)
Product code: HAW Neurological Stereotaxic Instrument
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.
FDA root cause: Process control
Action: The firm began notifying customers on September 24, 2026 via Urgent Medical Device Recall letters. Customers were instructed to immediately locate and quarantine any affected products at their facility. Customers may either destroy affected products onsite with their Stryker representative and send a completed Certificate of Destruction to the firm, or return the products to Stryker. The firm will provide a replacement upon receipt of the recalled product or Certificate of Destruction.
Quantity in commerce: 513
Distribution: Worldwide - US Nationwide distribution in the states of Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington and the countries of Austria, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Norway, Portugal, South Korea, Spain, Switzerland, UK.
Product codes and lots: Lot 7000413361 UDI-DI 07613327413205

Product code HAW

K212194Class IIStryker 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

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-03. View this recall on fda.gov (opens on fda.gov)