U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A complaint was received where the hiploc plate/lag screw introducer was undersized and would not accept the introducor coupling screw. it appears now that not all parts manufactured to rev a drawing were reworked.
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Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The following actions are REQUIRED:
Immediately locate and remove the identified device(s) listed below from circulation.
Remove the affected product from circulation.
Review this notification and ensure that all affected personnel are aware of its contents.
Carefully follow the instructions on the enclosed Response Form .
Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product.
You do not need to complete the Biomet UK response form.
Use priority carrier for your shipment.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
"Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or
"Call (800)FDA-1088
Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
“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.