Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws 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 is an FDA Class II recall involving a device malfunction (locking screw passing through the locking hole) that presents risk of surgical complications. However, the source text does not report any injuries, hospitalizations, or patient harm—only surgical delays. Per the rubric, this corresponds to score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling 209 units of the A.L.P.S. mvX Medial Tibia Plate, 10-Hole, Right (Model 770715102). This medical device is designed to fixate fractures of the distal tibia. The recall affects units with lot numbers 265815, 24055DF03, and 24055DF04 that were distributed nationwide.
The device has been recalled due to complaints of the locking screw passing through the locking hole during surgical implantation. This malfunction occurs intra-operatively and has resulted in reported surgical delays during the implantation procedure.
This is an FDA Class II recall. Healthcare providers who may have received or used these devices should verify their inventory against the affected lot numbers.
The recalled product
- Product
- A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
- Manufacturer
- Tyber Medical
- Hazard
- device-malfunction
- surgical-complication
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 00196449016006
- Lot Numbers 265815
- 24055DF03
- 24055DF04
Distribution
Distributed nationwide across the United States.
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