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.
There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. there could be a delay in surgery to remove the ball plunger. if the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal.
조치
Zimmer sent an URGENT MEDICAL DEVICE RECALL LETTER dated October 21, 2010, to all affected customers. The letter identified the product, the problem, the action to be taken by the customer.
Customers were instructed to:
Inspect their inventory, stop using the device, and place it in quarantine.
Contact Zimmer Customer Service at 1-800-774-6368 to obtain a return authorization number.
Complete the Inventory Return Certification form and fax a copy to (952) 837-6958, or scan and email to qualitycompliance@zimmer.com.
Return the recalled product along with the original completed Return Certification Form to:
Zimmer Spine, Inc.
Attn: RA Receiving
5301 Riata Park Ct.
Austin, Texas 78727
For questions regarding this recall call Zimmer Spine Customer Service at 1-866-774-6368.
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Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.
제품 설명
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. || The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.
“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.