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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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GM Helix Acqua Implant, Article Number: 140.985
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2
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05/28/2025
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FEI # 1000121052 Straumann USA LLC
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GM Helix Acqua Implant, Article Number: 140.984
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2
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05/28/2025
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FEI # 1000121052 Straumann USA LLC
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GM Helix Acqua Implant 3.5x10, Article No. 140.944
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2
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11/04/2021
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FEI # 3008261720 Jjgc Industria E Comercio De Materials Dentarios Sa
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FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a labe...
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2
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08/02/2016
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FEI # 1000517638 Medtronic Navigation, Inc.
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External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), ...
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2
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02/20/2014
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FEI # 1000592496 BioHorizons Implant Systems Inc
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ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant
C...
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2
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05/18/2023
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FEI # 3007135442 Hiossen Inc.
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EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected ...
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2
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06/14/2007
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FEI # 1038806 Biomet 3i
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EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected...
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2
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10/21/2004
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FEI # 1038806 Implant Innovations, Inc.
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DAL-RO Threaded Female
Dental implants
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2
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08/12/2016
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FEI # 1038806 Biomet 3i, LLC
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DAL-RO Housing, Female Assembly
Dental implants
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2
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08/12/2016
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FEI # 1038806 Biomet 3i, LLC
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