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Straumann Manufacturing Recalls
11 recalls on record · August 24, 2016 to November 21, 2018 · Medical Devices
Recalls by year
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 21, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be i
Hazard: Laser engraved label does not match with the item in the package
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
May 16, 2018Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
Hazard: A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
January 18, 2017Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental
Hazard: Drills cannot be inserted into handpiece due to tolerance specification not met
January 18, 2017Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Denta
Hazard: Drills cannot be inserted into handpiece due to tolerance specification not met
August 24, 2016Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Hazard: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
August 24, 2016Medical DevicesFDA
Straumann Manufacturing, Inc. recalls Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Hazard: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration