Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm orthopedic device with a documented mechanical defect that causes surgical complications. Although no injuries or illnesses have been reported, the defect presents a real risk during surgery.
Plain-English summary
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates, 6-hole, left (Model 770708061), used for fixation of distal tibia fractures. The affected lot numbers are 267846, 265782, 24043BU04, and 261288. Approximately 418 units were distributed nationwide.
During surgery, the locking screw on affected plates can pass through the locking hole, causing surgical delays. Surgeons should immediately stop using affected plates and contact Tyber Medical for replacements or alternative fixation guidance.
Patients with existing implants from these lot numbers should contact their surgeon to discuss the recall.
The recalled product
- Product
- A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
- Manufacturer
- Tyber Medical
- Affected units
- 418
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI 00196449015542
- Lot Numbers 267846
- 265782
- 24043BU04
- 261288
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Tyber Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Tyber Medical
See all →- ModerateLong distal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
- ModerateDistal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
- HighMedical plate locking screw may fail during fracture surgery
FDA (Devices) · 2025-03-05
- HighOrthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
FDA (Devices) · 2025-03-05
- HighMedial tibia plate screw locking defect causes surgical delays
FDA (Devices) · 2025-03-05
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