Medial Tibia Plate Recall Due to Locking Screw Malfunction During Surgery
Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing 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: FDA Class II recall involving a mechanical failure of a surgical device that occurs during patient procedures. While the hazard poses real intra-operative risk, no injuries, illnesses, or hospitalizations have been reported. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling 109 units of the A.L.P.S. mvX Medial Tibia Plate (Model 770715162) distributed nationwide. This surgical device is used to fix fractures of the distal tibia.
The recall is due to complaints that the locking screw can pass through the locking hole during surgical use. Surgical delays have been reported as a result.
The affected lot numbers are 24053DF02, 24070DF02, and 24057DF01. Healthcare providers using this device should be aware of this mechanical failure risk.
The recalled product
- Product
- A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162
- Manufacturer
- Tyber Medical
- Affected units
- 109
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 00196449016044
- Lot Numbers 24053DF02
- 24070DF02
- 24057DF01
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
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- ModerateDistal radius plates recalled over an incorrect thread orientation
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- 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
Same hazard · hardware malfunction
See all →- HighAlphatec Insignia Anterior Cervical Plate System screw locking mechanism failure
FDA (Devices) · 2021-06-16
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