FDA Medical devices recall ·
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm recall
- Recall number
- Z-2361-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Medartis AG
Hochbergerstrasse 60e, Basel Town, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Why was it recalled?
The cannulation of the CCS screw is not centered.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Distribution
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
States: California Indiana Louisiana North Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2361-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.