Anatomic Lateral Fibula Plate recalled for locking screw malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to reports of locking screws passing through the locking hole during surgery, causing surgical delays.
What this means for you
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: FDA Class II device with reported intraoperative malfunction causing surgical delays. No deaths or documented injuries are explicitly reported in the source; the hazard is a functional defect during use rather than confirmed patient harm, placing this in the risk-of-harm category without yet-reported injury.
Plain-English summary
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates, 4-hole left models (Model/Catalog Number 770708041), because the locking screws can pass through the locking hole intraoperatively during use. This defect has caused surgical delays in reported cases. The affected lots are 24043BU03, 267844, 24043BU02, and 261286, with 412 units distributed nationwide.
This surgical fixation device is intended for use in fracture repair of the distal tibia. When the locking screw passes through the hole during surgery, it disrupts the surgical procedure and requires intervention, extending operative time.
Healthcare facilities and surgeons who use or have used these devices should contact Tyber Medical immediately regarding the recall. Patients who have received this implant should consult with their surgeon regarding their individual circumstances. The FDA has classified this recall as Class II.
The recalled product
- Product
- A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
- Manufacturer
- Tyber Medical
- Hazard
- fastener-failure
- surgical-malfunction
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
- 00196449015528 Lot Numbers 24043BU03
- 267844
- 24043BU02
- 261286
Distribution
Distributed nationwide across the United States.
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