Orthopedic tibia plate locking screw failure causes surgical delays
Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can 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: FDA Class II recall with a documented functional failure of the locking mechanism occurring during actual use, but no reported patient injuries to date. This fits the High severity criterion for 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 6H LT (Model 770715061), a surgical plate designed to fix fractures of the distal tibia. This recall affects 197 units distributed nationwide, including lot numbers 265790, 263514, 24055DF05, and 24056DF01.
During surgery, the locking screw can pass through the locking hole, causing intraoperative problems and surgical delays. This failure prevents the plate from properly securing the fracture.
The FDA has classified this as a Class II recall. Healthcare providers and patients who may be affected should be aware of this issue.
The recalled product
- Product
- A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
- Manufacturer
- Tyber Medical
- Hazard
- locking-mechanism-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 (5)
- UDI-DI 00196449015979
- Lot Numbers 265790
- 263514
- 24055DF05
- 24056DF01
Distribution
Distributed nationwide across the United States.
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