Orthopedic fibula plate locking screw failure during surgery
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.
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: A Class II recall involving a surgical implant with documented functional failure during use (locking screw passing through locking hole), resulting in surgical delays. No injuries or illnesses are explicitly reported. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported, yielding a score of 3.
Plain-English summary
Tyber Medical is recalling the A.L.P.S. mvX Anatomic Lateral Fibula Plate, Model 770708042. The recall affects 397 units distributed nationwide, with lot numbers 267845, 261287, 265780, and 24033BU01.
Complaints indicate that the locking screw can pass through the locking hole during surgery (intra-operatively). Surgical delays have been reported during use of the affected devices. This is classified as a Class II recall by the FDA.
Patients who may have received this implant should contact their surgeon or healthcare provider about this recall. Healthcare facilities should verify lot numbers in their inventory and follow instructions from Tyber Medical.
The recalled product
- Product
- A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
- Manufacturer
- Tyber Medical
- Affected units
- 397
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 00196449015535
- Lot Numbers 267845
- 261287
- 265780
- 24033BU01
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
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