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Recall Observatory FDA recall evidence

Device product

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

Z-2361-2026

April 24, 2026

Class II

Product summary

Firm
Medartis AG
Event
Event 98952
Status
Ongoing
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-2361-2026

Official wording

Reason: The cannulation of the CCS screw is not centered.

Code information: UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997

Distribution pattern: US Nationwide distribution in the states of LA, TX. IN, CA, NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The cannulation of the CCS screw is not centered.