Stryker Precision Pointer Electromagnetic recalled for fracture risk
Stryker Leibinger is recalling Precision Pointer Electromagnetic devices because the pointer tube can crack at a laser-welded joint during use. If that happens, loose parts could fall out while the device is inside a patient. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Stryker recalls
What to do
- Check whether you have lot 7000413361 (UDI 07613327413205).
- Stop using affected units and set them aside.
- Contact Stryker Leibinger for guidance on return or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Precision Pointer Electromagnetic (8000-050-001)
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 513
- Illnesses reported
- None reported
- Manufactured in
- Botzinger Str. 39-41, Freiburg Im Breisgau, Germany
- Classification
- Class II
- Recall number
- Z-0314-2027
In the FDA's words
- Description
- Precision Pointer Electromagnetic (8000-050-001) 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. 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. Affected quantity: 513
- Hazard
- 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.