CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
C2244.4308 Conelog Titanium Base CC ¿4.3GH2 8 inkl HS recalled
Camlog U is recalling C2244.4308 Conelog Titanium Base CC ¿4.3GH2 8 inkl HS, distributed in Colorado, Illinois, Maryland, New Hampshire. The recall was initiated on 28 Aug 2013 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-2205-2013
- FDA event ID
- 66143
- Recalling firm
- Camlog U, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2013
- FDA classified
- 16 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 28 Aug 2013 | Recall initiated by company | |
| 16 Sep 2013 | Classified by FDA | +19 days |
| 25 Sep 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product not cleared for sale/use in the United States.
Product as listed by the FDA
C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
Where it was distributed
USA Distribution in the states of NH, MD, CO, and IL.
Questions about this recall
Is C2244.4308 Conelog Titanium Base CC ¿4.3GH2 8 inkl HS recalled?
Yes. Camlog U recalled C2244.4308 Conelog Titanium Base CC ¿4.3GH2 8 inkl HS on 28 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2205-2013.
Why was it recalled?
Product not cleared for sale/use in the United States.
Which lots are affected?
4460 and 44163
Where was it sold?
USA Distribution in the states of NH, MD, CO, and IL.
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 Camlog U
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | C2244.3808, Conelog Titanium Base CC ¿3.8GH0.8 inkl HS recalled | Camlog U | Other | 4 states |
| Device | CLASS II | C2244.3820;, Conelog Titanium Base CC ¿3.8GH2.0 inkl HS recalled | Camlog U | Other | 4 states |
| Device | CLASS II | C2244.5008 Conelog Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM recalled | Camlog U | Other | 4 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |