← FDA ENFORCEMENT
Z-2361-2026Class II

Medartis AG

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 openFDA enforcement API. 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.