Anatomic lateral fibula plate locking screw failure during surgery
Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its 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 no reported injuries or illnesses. The locking screw malfunction during surgery represents a risk of harm during operative procedures, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Tyber Medical A.L.P.S. mvX Anatomic Lateral Fibula Plate (Model 770708102) is subject to a Class II FDA recall. This orthopedic fixation device is intended for fixation of fractures of the distal tibia. A total of 219 units have been distributed nationwide.
Complaints have been received that the locking screw can pass through the locking hole during intraoperative use. This mechanical defect has caused surgical delays. The affected lot numbers are 265810, 260892, and 262559 (UDI-DI 00196449015597).
Healthcare facilities and providers should check for affected units and contact Tyber Medical for recall instructions. Patients and providers should consult with their healthcare team regarding any questions or concerns about this device.
The recalled product
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description:
- Manufacturer
- Tyber Medical
- Hazard
- mechanical-failure
- surgical-delay
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 00196449015597
- Lot Numbers 265810
- 260892
- 262559
Distribution
Distributed nationwide across the United States.
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