Quick Facts at a Glance
- Recall Date
- January 9, 2026
- Hazard Level
- HIGH
- Brand
- Medartis AG
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medartis AG
- Product type
- 2.8 TriLock Screw 16mm (HD7)
- Model numbers
- A-5850.16/1, HD7, 25467933
- Sizes
- 16mm
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 9, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medartis AG or your healthcare provider for instructions. Notification method: Letter
About This Product
The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
Why This Is Dangerous
A mix-up between 2.5mm and 2.8mm outer diameter screws can result in implant mismatch and potential fixation issues during surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Surgeons and patients worldwide may be affected. The practical impact centers on stopping use and ensuring correct implants are used to avoid fixation failure.
Practical Guidance
How to identify if yours is affected
- Verify device label A-5850.16/1 and HD7 on the packaging.
- Check outer diameter and length against the recalled specifications (2.8mm x 16mm).
- Cross-check lot code 25467933 against the recall list.
Where to find product info
FDA recall notice Z-1550-2026 and the Medartis recall notice. Visit the FDA enforcement page linked in the recall posting.
What timeline to expect
Manufacturer guidance provided; no specific replacement timeline published. Hospitals should follow the recall instructions.
If the manufacturer is unresponsive
- Escalate through hospital risk management or procurement.
- File a formal inquiry with the FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Implement strict lot-control verification for implants.
- Require surgeons to double-check screw size and diameter before implantation.
- Regularly review FDA recall databases for orthopedic implants.
Documentation advice
Document device lot numbers, serials, and communications with Medartis and hospital records; keep copies of recall notices.
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Product Details
Model/Catalog: A-5850.16/1. 1/Pkg. Lot: 25467933. Device: APTUS fixation system screws. Sizes: 2.8mm outer diameter, 16mm length. HD7 variant. Sold worldwide; US distribution in Indiana and Pennsylvania.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model/Catalog A-5850.16/1; HD7; Lot 25467933
- Distributed worldwide including US (Indiana, Pennsylvania) and countries listed in recall
- Hazard: mix-up between 2.5mm and 2.8mm screws
- Recall date 2026-01-09; FDA notice Z-1550-2026
- Follow manufacturer recall instructions and stop use
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Safety Guide
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