FDAFDA · Food and drugs·Recall number Z-1213-2025
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
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 00196449015566; Lot Numbers 265784, 24043BU01, 261290
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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