The FDA has posted 5 enforcement recalls of orthopedic manual surgical instrument devices since 2025, none of them Class I (most serious). Most recent report: Apr 23, 2025.
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Device is missing the pin in the graft loader component.
Device is missing the pin in the graft loader component.
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Orthopedic Manual Surgical Instrument”). Informational only — verify against the FDA before acting.