FDA Recall
Open, Classified
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Recall: Z-2361-2026
·
Initiated April 24, 2026
Recall
- Recall Number
- Z-2361-2026
- Event Number
- 98952
- Firm
- Medartis AG Hochbergerstrasse 60e Basel Town Switzerland
- FEI Number
- 3003236702
- Product Code
- HWC
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- April 24, 2026
- Posted
- June 9, 2026
Description
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.
Action
Medartis issued an URGENT: Field Safety Notice - Recall to its consignees on 5/4/2026 via USPS. The notice explained the problem with the device, potential risks associated with its use, intraoperatively and postoperatively, and provided postoperative patient recommendations. Response to the Field Safety Notice should be made to: [email protected] or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned.
Distribution
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Quantity
13 units