FDA-Device2026-06-17Class IIPROCESSING DEFECT
Medartis APTUS cannulated compression screws recalled for misaligned cannulation
What this means
Medartis has recalled certain APTUS 5.0 headed cannulated compression screws (CCS) used in bone fixation surgery because the central hole in the screw is not properly centered. This affects 13 units across five states. No injuries have been reported.
- If you received or used this screw (REF A-8216.50/1, Lot 25444702, 24425542, 24404471, or 25441997), contact Medartis immediately.
- Do not use affected screws in new procedures.
- For existing implants, consult your surgeon about whether follow-up care is needed.
The agency's original wording
Hazard
The cannulation of the CCS screw is not centered.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Affected count
13 units
Manufactured in
Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
Products
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2361-2026Want us to check the next one for you?
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