← FDA ENFORCEMENT
Z-2361-2026Class II
Medartis AG
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Medartis AG
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Firm state
N/A
Product quantity
13 units
Initiated by
Voluntary: Firm initiated
Reason for recall
The cannulation of the CCS screw is not centered.
Product description
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Code / lot info
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →