Orthopedic Plate Locking Screw May Pass Through Hole During Surgery
Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass 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: This is an FDA Class II medical device with reported device failures (locking screw passing through the locking hole during surgery) that could compromise fracture fixation. While no patient injuries have been explicitly reported, the device presents a direct risk of harm requiring corrective surgical intervention.
Plain-English summary
Tyber Medical is recalling 100 units of the A.L.P.S. mvX-P Anatomic Lateral Fibula Plate, Model 770708121, nationwide. This orthopedic plate is intended for fixation of fractures of the distal tibia.
The FDA Class II recall was issued due to complaints that the locking screw may pass through the locking hole during surgery. Surgical delays have been reported with use of the device.
The recalled lot numbers are 262560 and 260893. Patients who have received or are scheduled to receive this device should consult with their healthcare provider.
The recalled product
- Product
- A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121
- Manufacturer
- Tyber Medical
- Hazard
- implant-failure
- device-malfunction
- component-dislocation
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 (3)
- UDI-DI 00196449015603
- Lot Numbers 262560
- 260893
Distribution
Distributed nationwide across the United States.
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