Class 2 Device Recall Precision Pointer Electromagnetic

• Date Initiated by Firm: September 24, 2026
• Date Posted: October 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0314-2027
• Recall Event ID: 99855
• 510(K)Number: K212194
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Precision Pointer Electromagnetic (8000-050-001)
• Code Information: Lot 7000413361 UDI-DI 07613327413205
• FEI Number: 3002821504
• Recalling Firm/ Manufacturer: Stryker Leibinger GmbH & Co. KG; Botzinger Str. 39-41; Freiburg Im Breisgau Germany
• For Additional Information Contact: Katharina Feige-Goetz; +497614512-0 Ext. 0
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HAW