A.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery
Tyber Medical is recalling 408 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate because the locking screw can pass through the locking hole during surgery, causing surgical delays. No injuries have been reported.
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 a Class II medical device recall involving a mechanical failure of a surgical implant during use. Actual complaints and surgical delays have been documented, but no injuries or hospitalizations have been reported. This qualifies as a risk-of-harm product where injury has not yet occurred.
Plain-English summary
Tyber Medical is recalling the A.L.P.S. mvX Anatomic Lateral Fibula Plate, Model 770708062, a surgical implant used in orthopedic procedures to stabilize fractures. The recall affects 408 units distributed nationwide with lot numbers 265783, 267847, 24036BU02, and 261289 (UDI-DI: 00196449015559).
The FDA received complaints that the locking screw can pass through the locking hole during surgical use (intra-operatively), causing the implant to malfunction. This mechanical failure has resulted in reported surgical delays during procedures.
Healthcare facilities should verify their inventory against the affected lot numbers and discontinue use of the affected devices. Surgeons and healthcare providers should contact Tyber Medical for instructions on device return or replacement. Patients who have received this implant should consult their surgeon if they have any concerns about their procedure.
The recalled product
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
- Manufacturer
- Tyber Medical
- Affected units
- 408
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 (5)
- UDI-DI 00196449015559
- Lot Numbers 265783
- 267847
- 24036BU02
- 261289
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.
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