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.
The firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
조치
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
제품 설명
Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER, REF 00-5901-040-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN || This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
“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.