Recall Z-2361-2026 ยท HWC Screw, Fixation, Bone
Medartis AG
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
| Date | Jun 9, 2026 (initiated Apr 24, 2026) |
| Status | Open, Classified |
| Reason | The cannulation of the CCS screw is not centered. |
| Root cause | Under Investigation by firm |
| 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: fieldaction.us@medartis.com or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned. |
| Quantity | 13 units |
| Distribution | US Nationwide distribution in the states of LA, TX. IN, CA, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System Medartis AG, Nov 6, 2020 |