FDAFDA · Food and drugs·Recall number Z-1821-2024
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Published May 22, 2024 · Recall initiated: April 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Screw is 16mm long instead of 22mm long.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medartis Inc.
- Distributor
- Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
- Lot
- Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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