Device recall
Precision Pointer Electromagnetic (8000-050-001)
- Recall number
- Z-0314-2027
- Event id
- 99855
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Report date
- Nov 4, 2026
- Posted
- Oct 29, 2026
- Initiated
- Sep 24, 2026
- Center classification date
- Oct 29, 2026
- Product code
- HAW
- Device type
- Neurological Stereotaxic Instrument
- 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.
- Root cause
- Process control
- Quantity
- 513
- Code info
- Lot 7000413361 UDI-DI 07613327413205
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K212194
- Location
- Freiburg Im Breisgau, Germany