Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may 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 of a surgical implant with a documented mechanical failure mode occurring intra-operatively. While no patient injuries or deaths have been reported, the device malfunction presents a risk of harm during surgery, fitting the rubric 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 Anatomic Lateral Fibula Plate, 8-hole, Right (Model 77070802), used to fixate fractures of the distal tibia. The recall affects 212 units distributed nationwide.
The locking screws in the A.L.P.S. mvX Anatomic Lateral Fibula Plate may pass through the locking hole while the device is being used during surgery. This malfunction has caused surgical delays.
Healthcare facilities that received these devices should immediately stop using the affected lot numbers: 265785, 24036BU01, and 261291 (UDI-DI 00196449015573). Patients and healthcare providers should contact Tyber Medical if they have questions about this recall.
The recalled product
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
- Manufacturer
- Tyber Medical
- Hazard
- mechanical-failure
- surgical-delay
- intra-operative-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 (4)
- UDI-DI 00196449015573
- Lot Numbers 265785
- 24036BU01
- 261291
Distribution
Distributed nationwide across the United States.
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