“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.
Description du dispositif
BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. || BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Description du dispositif
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW || An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Description du dispositif
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING || An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Description du dispositif
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER || An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Description du dispositif
BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER || An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation