Precision Pointer Electromagnetic (8000-050-001)
Stryker Leibinger GmbH & Co. KG · 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 insi…
Open FDA's page for this record- Cfres ID
- 222745
- Product res number
- Z-0314-2027
- Event date initiated
- 2026-09-24
- Event date posted
- 2026-10-29
- Recall status
- Open, Classified
- Res event number
- 99855
- Product code
- HAW
- Product description
- Precision Pointer Electromagnetic (8000-050-001)
- Code info
- Lot 7000413361 UDI-DI 07613327413205
- Firm FEI number
- 3002821504
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Address 1
- Botzinger Str. 39-41 39-41 botzinger str.
- City
- Freiburg Im Breisgau
- Country
- Germany
- Additional info contact
- Katharina Feige-Goetz +497614512-0 Ext. 0
- Root cause description
- Process control
- Product quantity
- 513
- 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.
- 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.
- Distribution pattern
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.
- K numbers
- K212194
- Harmonized identifiers (openFDA)
- Device name
- Neurological Stereotaxic Instrument
- Medical specialty description
- Neurology
- Regulation number
- 882.4560
- Device class
- 2
- K number
- K881132, K013025, K833484, K211544, K970865, K251317, K894263, K936019, K971675, K060556, K130874, K071714, K142024, K973277, K041477, K012448, K974187, K061479, K191422, K983539, K262214, K961639, K212397, K003699, K021760, K250505, K013861, K020631, K220072, K092239, K214040, K965139, K983669, K990860, K062086, K993501, K242575, K982570, K971247, K063607 +387 more
- Registration number
- 2134947, 3016438694, 3005075696, 3002808157, 3010123206, 3008534770, 3010202439, 3005161223, 9617840, 3010362364, 3015876273, 2183744, 3016577622, 3017603615, 3002807090, 8010379, 3033536255, 3008027912, 3010120104, 1219655, 1526534, 3014967969, 3012494290, 1928237, 1836357, 3010041430, 2182979, 1721983, 3017636737, 1723170, 3009293341, 3038503932, 1450662, 1643264, 3002743211, 3010049501, 3012469182, 2528981, 3015877656, 3011713200 +210 more
- FEI number
- 3016438694, 3002807830, 3002807847, 3005075696, 3003064967, 3003251135, 3002806773, 3002808157, 3010123206, 3008534770, 3005161223, 3010362364, 3015876273, 2183744, 3016577622, 3017603615, 3007282753, 3033536255, 3008027912, 3010120104, 1219655, 1526534, 3002821504, 3001452082, 3014967969, 3012494290, 1928237, 2182979, 3010041430, 3017636737, 3005233524, 3009293341, 3003076831, 3002929183, 3038503932, 1000221916, 1450662, 1643264, 3002980729, 3002743211 +210 more