Z-2361-2026 Class II Ongoing
FDA device recall Z-2361-2026 was initiated by Medartis AG on April 24, 2026 and is designated Class II. Reason for recall: The cannulation of the CCS screw is not centered. The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Reason for Recall
The cannulation of the CCS screw is not centered.
Distribution Pattern
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Code Information
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997