Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixati
FDA device recall Z-2361-2026 · posted 2026-06-09 · Open, Classified
Recall details
- Recalling firm
- Medartis AG
- Reason for recall
- The cannulation of the CCS screw is not centered.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 13 units
- Distribution
- US Nationwide distribution in the states of LA, TX. IN, CA, NC.
- Date initiated
- 2026-04-24
- Date posted
- 2026-06-09
- Location
- Basel Town, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (K202589) | Medartis AG | 2020-11-06 |