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CLASS II · ModerateFDA

Stryker Leibinger GmbH & Co. KG recalls Precision Pointer Electromagnetic

📅 Sep 24, 2026 · 📍 Nationwide
Recalling company
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 24, 2026
Reported
Nov 4, 2026
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.
Status
Ongoing
Quantity
513
Lot / codes
Lot 7000413361 UDI-DI 07613327413205
Company location
Freiburg Im Breisgau
Recall type
Voluntary: Firm initiated
Recall number
Z-0314-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0314-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.