CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
A.L.P.S. mvX--Medial Tibia Plate 12H Rt-Medial Tibia Plate recalled
Tyber Medical is recalling A.L.P.S. mvX--Medial Tibia Plate 12H Rt-Medial Tibia Plate, 12-Hole, Right Intended for, distributed nationwide in the US. The recall was initiated on 21 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1224-2025
- FDA event ID
- 96212
- Recalling firm
- Tyber Medical, Bethlehem, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2025
- FDA classified
- 21 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Jan 2025 | Recall initiated by company | |
| 21 Feb 2025 | Classified by FDA | +31 days |
| 5 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Product as listed by the FDA
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Which lots are affected?
UDI-DI 00196449016020; Lot Numbers 265817, 24060DF08, 263511, 24057DF02, 24057DF04
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 96212This product is part of a recall event; the main page for the event is A.L.P.S. mvX-Medial Tibia Plate 12H Lt-Medial Tibia Plate recalled.
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