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.
Zimmer biomet initiated a voluntary recall of the twist drill & v-tek twist drill due to to a potential tolerance stack up identified between the twist drill and the mating kirschner wire (k-wire) component.
조치
Zimmer GmbH initiated a voluntary recall of the Normed - TWIST DRILL Cannulated & Normed- V-TEK TWIST DRILL Cannulated, with written notices on June 27, 2016 via certified mail due to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. Customers are asked to do the following: Review the notification and ensure affected personnel are aware of the contents.
2. Locate all affected product identified above and quarantine them immediately.
3. Return any affected product within your possession. Clearly mark the outside of all return packages,
Recall, and include a copy of the Inventory Return Certification form (Attachment 1) with your return
shipment(s).
4. If after reviewing this notification you have further questions or concerns please call the customer
call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
" Online:www.fda.gov/medwatch/report.htm
" Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to address on the pre-addressed form.
" Fax: 1-800-FDA-0178
Affected units returned as part of this recall activity will be scrapped
Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay
제품 설명
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
“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.