Recall Z-0314-2027 ยท HAW Neurological Stereotaxic Instrument
Stryker Leibinger GmbH & Co. KG
Precision Pointer Electromagnetic (8000-050-001)
| Date | Oct 29, 2026 (initiated Sep 24, 2026) |
| Status | Open, Classified |
| 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 |
| 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 | 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, Tenne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Na Stryker Corporation, Feb 16, 2023 |