CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Aptus 2.8 TriLock Screw, HD7, 1/Pkg recalled by Medartis
Medartis is recalling Aptus 2.8 TriLock Screw, HD7, 1/Pkg, distributed nationwide in the US. The recall was initiated on 12 Apr 2024 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-1821-2024
- FDA event ID
- 94445
- Recalling firm
- Medartis, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Apr 2024
- FDA classified
- 14 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 12 Apr 2024 | Recall initiated by company | |
| 14 May 2024 | Classified by FDA | +32 days |
| 22 May 2024 | 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
Screw is 16mm long instead of 22mm long.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Where it was distributed
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Questions about this recall
Why was it recalled?
Screw is 16mm long instead of 22mm long.
Which lots are affected?
Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Where was it sold?
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
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.
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 2.5 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG | Medartis | Device Malfunction | Nationwide |
| Device | CLASS II | Aptus Ulna Shortening recalled by Medartis | Medartis | Device Malfunction | Nationwide |
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