Orthopedic plate recall: locking screw may pass through hole during surgery
Tyber Medical is recalling 214 units of A.L.P.S. mvX orthopedic plates (nationwide) because the locking screw may pass through the locking hole during surgery. Surgical delays 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: This is a Class II recall for an orthopedic implant with documented mechanical failure during surgery. The source text reports surgical delays but does not indicate any reported injuries, hospitalizations, or deaths, placing it within the High severity tier for risk-of-harm products without yet-reported injury.
Plain-English summary
Tyber Medical is recalling 214 units of A.L.P.S. mvX Anatomic Lateral Fibula Plate, 8-hole, Left (Model/Catalog Number 770708081), an orthopedic implant intended to stabilize bone fragments during healing. The product is distributed nationwide. Affected units are identified by UDI-DI 00196449015566 and lot numbers 265784, 24043BU01, and 261290.
The recall was initiated because the locking screw can pass through the locking hole during surgery (intra-operatively). This device malfunction has been documented in multiple complaints received by the manufacturer and FDA.
Patients who have received or are scheduled to receive this implant should contact their surgeon or healthcare provider immediately. Healthcare facilities should check their inventory for the affected lot numbers and take appropriate action. Surgical delays have been reported as a result of this defect.
The recalled product
- Product
- A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
- Manufacturer
- Tyber Medical
- Hazard
- mechanical-failure
- 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 (4)
- UDI-DI 00196449015566
- Lot Numbers 265784
- 24043BU01
- 261290
Distribution
Distributed nationwide across the United States.
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