Quick Facts at a Glance
- Recall Date
- January 9, 2026
- Hazard Level
- HIGH
- Brand
- Medartis
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Product type
- Orthopedic fixation screw
- Model numbers
- A-5750.16/1, HD7, 25472432
- Sizes
- 16mm
- Sold at
- Unknown
- 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/Medartis fixation system is used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. The subject screw is a 2.5 TriLock locking screw used in various fixation procedures.
Why This Is Dangerous
A mix-up between 2.5mm and 2.8mm outer diameter screws could result in selecting an incorrect screw size during a fixation procedure, potentially affecting implant stability.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The issue requires clinical review and potential re-operation if mis-sized screws were used. No injuries have been reported to date, but the possibility of implant-related complications exists until the device is removed or replaced per instructions.
Practical Guidance
How to identify if yours is affected
- Check model A-5750.16/1 and lot 25472432 on packaging
- Confirm screw diameter; ensure it is 2.5mm and not 2.8mm
- Review surgical implants inventory with the surgeon or distributor
- Refer to recall instructions from Medartis AG for next steps
Where to find product info
Identify numbers on device packaging and inserts; Model A-5750.16/1; Lot 25472432
What timeline to expect
4-6 weeks for refund or replacement processing in typical cases
If the manufacturer is unresponsive
- Escalate to hospital procurement or medical device distributor
- File a patient safety complaint with the FDA if necessary
- Keep all correspondence and documentation of recall notices
How to prevent similar issues
- Verify exact screw size before implantation
- Maintain strict lot-control and packaging review protocols
- Require surgeon confirmation of screw diameter before use
- Monitor regulatory updates and recall notices for devices in use
Documentation advice
Keep recall notices, packaging, lot numbers, photos, and all correspondence with supplier or hospital records for future reference
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Product Details
Model/Catalog Number: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm Lot Code: 25472432 Distribution: Worldwide; US distribution includes Indiana and Pennsylvania; Countries cited: Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, Poland Sold at: Unknown Price: Unknown Date Sold: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: Medartis AG
- Product: 2.5 TriLock Screw 16mm HD7 (A-5750.16/1)
- Hazard: mix-up between 2.5mm and 2.8mm outer diameter screws
- Status: ACTIVE recall (2026)
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Safety Guide
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