FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that 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: This FDA Class II recall addresses a mechanical failure in the device's locking mechanism occurring during use. While surgical delays have been reported, the source text does not document patient injuries or hospitalizations. It meets the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling the A.L.P.S. mvX Medial Tibia Plate, 12-Hole, Left (Model 770715121). This device is an orthopedic fixation plate intended for surgical fixation of distal tibia fractures and was distributed nationwide.
The recall was issued due to complaints that the locking screw can pass through the locking hole during intra-operative use. This mechanical failure has resulted in reported surgical delays. The affected lot numbers are: 265816, 24064DF01, 263557, 24065DF04, 24059DF03, and 24059DF02 (201 units total).
Healthcare facilities and surgical teams using these devices should discontinue use of affected lots immediately and contact Tyber Medical for replacement or return instructions. Patients who have received this implant should consult their surgeon regarding any concerns about their device.
The recalled product
- Product
- A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
- Manufacturer
- Tyber Medical
- Hazard
- mechanical-failure
- device-failure
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 (7)
- UDI-DI 00196449016013
- Lot Numbers 265816
- 24064DF01
- 263557
- 24065DF04
- 24059DF03
- 24059DF02
Distribution
Distributed nationwide across the United States.
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