CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
Aptus 2.5 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG
Medartis is recalling Aptus 2.5 TriLock Screw, HD7, 1/Pkg, distributed nationwide in the US. The recall was initiated on 9 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1549-2026
- FDA event ID
- 98353
- Recalling firm
- Medartis, Basel Town, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2026
- FDA classified
- 10 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Jan 2026 | Recall initiated by company | |
| 10 Mar 2026 | Classified by FDA | +60 days |
| 18 Mar 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Where it was distributed
Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
Questions about this recall
Why was it recalled?
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Which lots are affected?
Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Where was it sold?
Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98353| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aptus 2.8 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG | Medartis | Device Malfunction | Nationwide |
More recalls from Medartis
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aptus, 5.0 headedCCS Long Thread recalled by Medartis AG | Medartis | Other | Nationwide |
| Device | CLASS II | Aptus 2.8 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG | Medartis | Device Malfunction | Nationwide |
| Device | CLASS II | Aptus 2.8 TriLock Screw, HD7, 1/Pkg recalled by Medartis | Medartis | Foreign Material | Nationwide |
| Device | CLASS II | Aptus Ulna Shortening recalled by Medartis | Medartis | Device Malfunction | Nationwide |
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