FDAFDA · Food and drugs·Recall number Z-1223-2025
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
Published March 5, 2025 · Recall initiated: January 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Tyber Medical
- Distributor
- Nationwide
- Lot
- UDI-DI 00196449016013; Lot Numbers 265816, 24064DF01, 263557, 24065DF04, 24059DF03, 24059DF02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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