Spinal FrontiersPowered by NSpineFDA posted a Class II recall on 29 October because the pointer tube may fracture at a laser-welded joint, and loose parts could fall out while the device is inside the patient; 513 units were distributed worldwide, including the UK and Germany. BfArM (25 Sep, ref. 43648/26) and ANSM (5 Oct, R2628768) had already listed action on the same pointer. The FDA record ties it to Stryker's cranial guidance 510(k) and does not mention spine, so we list it here rather than among spine recalls.
- Type
- Other regulatory action
- Company
- Stryker Leibinger (Stryker)
- Device
- Precision Pointer Electromagnetic (8000-050-001)
- Date
- 29 October 2026
- Jurisdiction
- US/DE/FR
- Classification
- FDA Class II recall (Z-0314-2027), initiated 24 Sep 2026, posted 29 Oct 2026; 510(k) K212194 (Q Guidance System with Cranial Guidance Software); earlier BfArM FSN (43648/26) and ANSM lot recall (R2628768)
- Source
- FDA Medical Device Recalls database
Official source →Source checked