FDA-Device2026-06-17Class IIPROCESSING DEFECT
Medartis APTUS cannulated compression screws recalled for misaligned cannulation
OTHERNationwide distribution
Medartis APTUS compression screws recalled for misaligned hole
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.
Hazard
The cannulation of the CCS screw is not centered.
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-2361-2026Don't want to check this manually?
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