Z-1821-2024 Class II Ongoing
FDA device recall Z-1821-2024 was initiated by Medartis Inc. on April 12, 2024 and is designated Class II. Reason for recall: Screw is 16mm long instead of 22mm long. The recall status is ongoing. Affected quantity: 110 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- April 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product Description
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Reason for Recall
Screw is 16mm long instead of 22mm long.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Code Information
Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.