FDA Medical Device Recalls (openFDA)
Medartis AG: Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Recall number
- Z-2361-2026
- Recalling firm
- Medartis AG
- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Status
- Open, Classified
- Initiated
- 2026-04-24
- Posted
- 2026-06-09
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
- 510(k) numbers
- ["K202589"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3003236702
- Firm city
- Basel Town
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28