Medartis APTUS cannulated compression screws recalled for misaligned cannulation
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 13 units
- Illnesses reported
- None reported
- Manufactured in
- Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
- Classification
- Class II
- Recall number
- Z-2361-2026
In the FDA's words
- Description
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation The cannulation of the CCS screw is not centered. UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997 Distribution: US Nationwide distribution in the states of LA, TX. IN, CA, NC. Affected quantity: 13 units
- Hazard
- The cannulation of the CCS screw is not centered.