Medartis Ag Hochbergerstrasse 60e Basel Town Switzerland: Screw, Fixation, Bone
Recall Summary Medartis AG is recalling certain Cannulated Compression Screws (APTUS model, 5.0 headed CCS Long Thread 50/20mm, REF A-8216.50/1) used for bone fixation surgery. The screws have a manufacturing defect where the center hole is not properly aligned. These devices were distributed nationwide across the United States. This is a Class II recall, meaning the defect could potentially cause serious health problems but is not expected to cause death.
- Recalling firm
- Medartis AG Hochbergerstrasse 60e Basel Town Switzerland
- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Reason
- The cannulation of the CCS screw is not centered.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e8ae9e25-9a27-45da-9611-6353086fed8c