FDA recall, , Moderate risk
Medartis APTUS Cannulated Compression Screws
Cannulated Compression Screws for bone fixation have an off-center cannulation.
Summary by Recall Canary from the FDA notice
What happened
Medartis AG, of Basel Town, Switzerland, recalled its Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg, a Cannulated Compression Screw for bone fixation, because the cannulation of the CCS screw is not centered. The recall began on April 24, 2026, and was added to the FDA's Enforcement Report on June 9, 2026.
The product was distributed nationwide in the states of LA, TX, IN, CA, and NC. The recall involves 13 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF a-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- UDI-DI
- 07630037887706
- 25444702
- 24425542
- 24404471
- 25441997
Recall details
- Company began the recall
- Sold in
- 5 states
US Nationwide distribution in the states of Louisiana, Texas. IN, California, North Carolina.
- Company
- Medartis AGBasel Town, Switzerland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98952
- Recall number
- Z-2361-2026
- Quantity recalled
- 13 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
