FDA Medical Device Recalls (openFDA)
Medartis Inc.: APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
- Recall number
- Z-1821-2024
- Recalling firm
- Medartis Inc.
- Product
- APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
- Status
- Open, Classified
- Initiated
- 2024-04-12
- Posted
- 2024-05-14
- Terminated
- not on file
- Reason
- Screw is 16mm long instead of 22mm long.
- Root cause
- Process control
- Action
- Consignees were sent an "URGENT: Field Safety Notice" via email and printed letter, dated 4/12/2024, notifying them of this recall event. Consignees are asked to locate and quarantine affected devices, coordinate the return of affected devices to their distributor, inform all users of the device of this recall event, and return the provided Customer Reply form with the relevant information. Customers with any questions can call Medartis at 574-241-6531 between 7:30 AM and 6:30 PM EST, Monday through Friday. Questions can also be sent via email to Complaints.US@Medartis.com.
- Quantity
- 110 units
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
- Lot, serial or model codes
- Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
- 510(k) numbers
- ["K091479"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3009540749
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
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