Stryker Leibinger Gmbh & Co. Kg: Neurological Stereotaxic Instrument

Recalling firm
Stryker Leibinger GmbH & Co. KG
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.
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-09-24
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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,...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0214e1bd-1ceb-452a-b934-d7b93d1e1f39