Medical plate locking screw may fail during fracture surgery
A locking screw in the A.L.P.S. mvX Medial Tibia Plate may pass through its locking hole during surgery. Surgical delays have been reported with this device.
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: Class II medical device with documented locking mechanism failure during surgery. The hazard is confirmed and causes surgical complications, but no injuries or hospitalizations are reported, meeting the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling the A.L.P.S. mvX Medial Tibia Plate 16H LT (Model 770715161), a surgical implant designed to stabilize distal tibia fractures. The affected lot numbers are 24061DF01, 24065DF02, and 24070DF01.
During surgical use, the locking screw in this device may pass through the locking hole. This malfunction has caused surgical delays in reported cases and can lead to intra-operative complications.
The affected devices were distributed nationwide. Healthcare facilities and surgeons using this device should review their inventory for the affected lot numbers.
Healthcare providers should contact Tyber Medical regarding the recall and any steps needed to address use of affected devices in patients.
The recalled product
- Product
- A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161
- Manufacturer
- Tyber Medical
- Hazard
- locking-mechanism-failure
- intra-operative-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 (4)
- UDI-DI 00196449016037
- Lot Numbers 24061DF01
- 24065DF02
- 24070DF01
Distribution
Distributed nationwide across the United States.
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