Medial tibia plate screw locking defect causes surgical delays
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may pass through the locking hole during surgery instead of securing properly, causing surgical delays. The recall affects 210 units distributed nationwide.
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: This is an FDA Class II surgical device with a functional defect (locking screw malfunction) that poses a risk of harm during the operative procedure. Although no injuries or hospitalizations have been reported, only surgical delays, the defect creates potential for implant failure and surgical complications. Per the severity rubric, Class II recalls without reported injuries where risk of harm exists are scored as High (3).
Plain-English summary
Tyber Medical is recalling the A.L.P.S. mvX Medial Tibia Plate (Model 770715062), a medical device used to stabilize fractures of the lower tibia bone. The device is designed to secure the bone using locking screws that pass through specific locking holes on the plate.
The company initiated the recall after complaints that the locking screw passes through the locking hole intra-operatively—during the surgical procedure itself—rather than securing as intended. This defect has resulted in surgical delays as surgeons address the malfunction.
The recall involves 210 units with lot numbers 265792, 24053DF01, 24065DF06, and 24052DF01, distributed nationwide. The affected devices are identified by UDI-DI 00196449015986.
Healthcare facilities and surgeons should immediately discontinue use of affected devices and contact Tyber Medical for instructions.
The recalled product
- Product
- A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
- Manufacturer
- Tyber Medical
- Hazard
- screw-malfunction
- implant-failure
- surgical-complication
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 00196449015986
- Lot Numbers 265792
- 24053DF01
- 24065DF06
- 24052DF01
Distribution
Distributed nationwide across the United States.
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