Medial Tibia Plate Recall: Locking Screw Defect During Surgery
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No 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 medical device with documented intra-operative failure causing surgical delays. No injuries or deaths have been reported. The device defect poses a risk of improper fracture fixation, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tyber Medical is recalling 200 units of A.L.P.S. mvX Medial Tibia Plates (Model 770715101) distributed nationwide. These medical devices are intended for fixation of fractures of the distal tibia.
The recall was initiated due to complaints that the locking screw may pass through the locking hole during intra-operative use. Surgical delays have been reported with this defect. Affected lot numbers are: 265814, 24060DF02, 24065DF03, 24060DF01, 24065DF05, and 263512. Devices can be identified using UDI-DI 00196449015993.
Healthcare providers who have used or dispensed this device should contact Tyber Medical for further instructions.
The recalled product
- Product
- A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
- Manufacturer
- Tyber Medical
- Hazard
- implant-defect
- device-malfunction
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 00196449015993
- Lot numbers 265814
- 24060DF02
- 24065DF03
- 24060DF01. 24065DF05
- 263512
Distribution
Distributed nationwide across the United States.
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