Medartis APTUS TriLock scaphoid plate recalled for incorrect bend
Medartis AG recalled one lot of its APTUS TriLock scaphoid bone plate, model A-4350.81, because the plate may be incorrectly bent. The notice reports no injuries. The 65 affected units were distributed nationwide, including in Indiana, Arizona, California, and New York.
From the FDA notice · Read the official notice ↗ · All Medartis recalls
What to do
- Check whether any units from lot 26508730 (UDI 07630894811647, model A-4350.81) are in your inventory, and set them aside.
- Contact Medartis AG about the affected lot. The notice does not say what remedy is available, so ask the manufacturer how to return or replace the units.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- APTUS 1.2/1.5 TriLock Scaph.Pl 3x2H Large,t0.8, Model/Catalog Number: A-4350.81; APTUS fixation systems are intended for temporary fixation, correction or stabilization of bones
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 65 units
- Illnesses reported
- None reported
- Manufactured in
- Hochbergerstrasse 60e, Basel Town, Switzerland
- Classification
- Class II
- Recall number
- Z-0433-2027
In the FDA's words
- Description
- APTUS 1.2/1.5 TriLock Scaph.Pl 3x2H Large,t0.8, Model/Catalog Number: A-4350.81; APTUS fixation systems are intended for temporary fixation, correction or stabilization of bones Plate is incorrectly bent UDI DI/GTIN: 07630894811647, Lot Number 26508730 Distribution: US Nationwide distribution in the states of IN, AZ, CA, NY. Affected quantity: 65 units
- Hazard
- Plate is incorrectly bent