Definition
PRECICE MAX is a titanium magnetic intramedullary system that received U.S. 510(k) clearance in December 2023. A separate Class II recall initiated in September 2024 lists specified catalog and lot combinations; the FDA record remained open when updated on July 14, 2026 and tells customers to stop using and return affected unimplanted devices. The record does not establish that every later or current unit is recalled or available, and the product name alone does not establish permitted loading or suitability. Verify the exact catalog number, UDI or lot, current instructions, and regulator and manufacturer status. [1][2]
Aliases
Precice MAX
Updated
Sources
- U.S. FDA - 510(k) Premarket Notification K232267: Precice Max SystemOfficial public sourceAccessed 2026-07-15
- U.S. FDA - Class 2 Device Recall: Precice Max (Z-0500-2025)Official public sourceAccessed 2026-07-15
The open recall record identifies affected catalog and lot combinations and was last updated July 14, 2026.
Informational only. Not medical advice.