CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Aptus, 0 headedCCS Long Thread recalled by Medartis AG
Medartis AG is recalling Medartis Aptus, 0 headedCCS Long Thread, distributed nationwide in the US. The recall was initiated on 24 Apr 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-2361-2026
- FDA event ID
- 98952
- Recalling firm
- Medartis AG, Basel Town, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2026
- FDA classified
- 9 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 24 Apr 2026 | Recall initiated by company | |
| 9 Jun 2026 | Classified by FDA | +46 days |
| 17 Jun 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
The cannulation of the CCS screw is not centered.
Product as listed by the FDA
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Where it was distributed
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Questions about this recall
Is Aptus, 0 headedCCS Long Thread recalled?
Yes. Medartis AG recalled Aptus, 0 headedCCS Long Thread on 24 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2361-2026.
Why was it recalled?
The cannulation of the CCS screw is not centered.
Which lots are affected?
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Where was it sold?
US Nationwide distribution in the states of LA, TX. IN, CA, NC.
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 21 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 AG
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|---|---|---|---|---|---|
| Device | CLASS II | Aptus 8 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG | Medartis AG | Device Malfunction | Nationwide |
| Device | CLASS II | Aptus 5 TriLock Screw, HD7, 1/Pkg recalled by Medartis AG | Medartis AG | Device Malfunction | Nationwide |
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