A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
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 involving a surgical implant where the locking mechanism can malfunction intra-operatively, causing surgical delays. No patient injuries or deaths have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling 208 units of the A.L.P.S. mvX Medial Tibia Plate, 12-Hole, Right (Model/Catalog Number 770715122), a surgical implant intended for fixation of distal tibia fractures.
The recall stems from complaints that the locking screw can pass through the locking hole during intra-operative use. This malfunction has resulted in surgical delays. No patient injuries or illnesses have been reported.
The affected devices were distributed nationwide across lot numbers 265817, 24060DF08, 263511, 24057DF02, and 24057DF04 (UDI-DI 00196449016020).
Surgeons and healthcare providers with these devices should contact Tyber Medical for guidance on replacement or further instructions regarding this recall.
The recalled product
- Product
- A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
- 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 (6)
- UDI-DI 00196449016020
- Lot Numbers 265817
- 24060DF08
- 263511
- 24057DF02
- 24057DF04
Distribution
Distributed nationwide across the United States.
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