The following recall was placed on the FDA Web site for immediate release to the public and healthcare professionals (http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html).“Ossur hf. (ICEX: OSSR) today announced a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee® prosthetic device. The company’s initiation of the recall, effective immediately, is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee.
“At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company. To date, the incidence of actual product failures within the recalled knees is less than one percent (1%).
“The serial numbers of the affected knees, which were ordered from June 7th, 2005 to present, have been identified. The O & P facilities who have provided a Total Knee that contains the affected serial number will receive a letter and a phone call with the proper replacement procedure in the next few days.
“In addition, Ossur has temporarily suspended sales and shipments of Total Knees until further notice. To expedite this process in the consideration of both its customers and patients, the implementation of a replacement program will be effective immediately.
“’We take the issue of patient safety very seriously,’ said Jon Sigurdsson, president and chief executive officer of Ossur. ‘We instituted this recall immediately, upon learning of the faulty pins, because we believe that the patient’s wellbeing is our first priority. In addition, we are taking measures to guarantee the quality and safety of the replacement knees.’â€
Ossur has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision to implement this recall.
The company will continue to provide regular and frequent updates as more information becomes available. You may also access the company website at www.ossur.com for this information, in real time.
If you have additional questions, you may contact Ossur at the following numbers:
United States & Canada: 800 233 6263 – Europe: +31 499 462 840 – Scandinavia: +46 1818 2200 – Asia-Pacific: +61 2 9630 9206 – Other countries: +354 515 1342.
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