Orthopedic Fixation Plates Recalled for Screw Locking Failure During Surgery
Tyber Medical is recalling 115 A.L.P.S. mvX orthopedic plates because the locking screw can pass through the locking hole during surgery, causing surgical delays and inadequate fracture fixation.
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 medical device recall involving a mechanical failure during intraoperative use. The locking screw passing through the locking hole represents a risk of inadequate fracture fixation and patient harm, though no injuries have been reported to date—only surgical delays.
Plain-English summary
Tyber Medical is recalling 115 units of A.L.P.S. mvX orthopedic plates, including both Medial Tibia and Anatomic Lateral Fibula configurations, used for fixation of tibia fractures. The affected model number is 770708122, with lot numbers 262571 and 260894.
The devices are being recalled because the locking screw can pass through the locking hole during surgery, preventing the plate from functioning properly. This intraoperative malfunction has caused surgical delays. The hazard is that inadequate fixation could result from this device failure.
The affected devices were distributed nationwide. Healthcare providers and surgical facilities that possess these devices should take appropriate action.
Healthcare providers and patients should contact Tyber Medical with questions or concerns about these devices.
The recalled product
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description:
- Manufacturer
- Tyber Medical
- Hazard
- screw-failure
- device-malfunction
- inadequate-fixation
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 00196449015610
- Lot Numbers 262571
- 260894
Distribution
Distributed nationwide across the United States.
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