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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 212
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.
Part of a larger recall action
This product is one of 18 recalled by Tyber Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Tyber Medical
See all →- ModerateLong distal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
- ModerateDistal radius plates recalled over an incorrect thread orientation
FDA (Devices) · 2026-01-28
- HighMedical plate locking screw may fail during fracture surgery
FDA (Devices) · 2025-03-05
- HighOrthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
FDA (Devices) · 2025-03-05
- HighMedial tibia plate screw locking defect causes surgical delays
FDA (Devices) · 2025-03-05
Same hazard · mechanical failure
See all →- HighBYD Recalls 2023-2024 Ride Type A School Buses for Lift Defect
NHTSA · 2026-10-22
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Similar recalls
- HighZimmer Fibular Plate Recall: Locking Hole Thread Form Defect
FDA (Devices) · 2024-05-08
- HighZimmer Distal Lateral Fibular Plate Recall: Locking Screw Malfunction Risk
FDA (Devices) · 2024-05-08
- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- HighZPLP Distal Lateral Fibular Plates Recalled for Defective Threading
FDA (Devices) · 2024-05-08
- HighZimmer Fibular Plate Recall: Defective Locking Hole Threading
FDA (Devices) · 2024-05-08
- HighZimmer Distal Lateral Fibular Plate Recall Due to Locking Thread Defect
FDA (Devices) · 2024-05-08