RegWardenFDA facility compliance records
Company

Tyber Medical LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 2 recalls20172018201920202021202220232024220252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-12-19
    The supplier manufactured anatomical left plates with an incorrect thread orientation.
  • Class IIOngoing2025-01-21
    Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Tyber Medical LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046574-tyber-medical-llc/

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