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Sulzer Medica to update on the Inter-Op acetabular shell recall
Only slight impact on hip sales in the US for the first two months of 2001 (02.03.2001, Media Release)
On December 8, 2000 Sulzer Orthopedics initiated the voluntary recall of certain lots of the shells immediately after the Company discovered an unacceptable level of residue of a mineral oil-based lubricant on the surface of some shells. Sulzer Orthopedics had determined that this residue may prevent the implant from properly bonding with the bone, causing the shells to loosen. The recall primarily concerns the US market of Sulzer Orthopedics. A number of lawsuits and class actions have been filed against Sulzer Orthopedics. The Company will defend itself against the certification of class action suits to address patients affected on an individual basis.
Sulzer Orthopedics has apologized for any effect the recall may have on patients and their families. The Company has taken full responsibility and addresses each patient’s needs and concerns on an individual basis, including reimbursement for expenses not covered by insurance or Medicare, such as lost wages and expenses related to surgery, and compensation for the patient’s pain and suffering.

Currently, three months after the official announcement of the recall, Sulzer Orthopedics is aware of 573 patients who have undergone revision surgery. The symptoms leading to revision surgery typically present within three months of surgery, sometimes extending up to six months. Because the company initiated the recall three months ago, the company believes that the frequency of revision surgery will begin to decrease in the near future. Due to the random nature of the problem, however, Sulzer Medica is not yet in a position to provide a final figure for the number of patients who eventually might need revision surgery. Surgeon advisers do not recommend that patients undergo removal of the Inter-Op unless they exhibit symptoms of loosening. Sulzer Medica regularly provides updates on the Inter-Op recall on its website www.sulzermedica.com.

As expected, the recall has slightly affected the growth of hip sales in the US in the first two months of 2001. Nevertheless, overall sales of joint prostheses are above the prior year. The Company believes that its product liability insurance is adequate to cover the cost associated with the revision surgeries and the associated claims to date. Non-insured losses associated with the recall to date are more than offset by an exceptional item of USD 32 Million from a litigation settlement.

Sulzer Orthopedics will defend itself against the certification of class action suits. The Company is convinced that patients are better served on a case-by-case basis as every patient who needs a revision is affected differently by the recall. Sulzer Orthopedics is also convinced that claims for punitive damages brought forward by some plaintiff attorneys will not be awarded because the company has acted responsibly and immediately once it learned about its manufacturing problem.

Headquartered in Winterthur, Switzerland, Sulzer Medica develops, manufactures and markets implantable medical devices and biological products for cardiovascular and orthopedic markets worldwide. The Company’s product offering includes joint prostheses, spinal implants, dental implants, trauma surgery products, heart valves, and vascular grafts (Swiss Stock Exchange: SMEN; NYSE: SM).

THE SAFE HARBOR STATEMENTS UNDER THE U.S. PRIVATE SECURITIES LITIGATION REFORM ACT 1995This report contains forward-looking statements including, but not limited to, projections of future performance of materials and products, financial conditions, results of operations and cash flows, containing risks and uncertainties. These statements are subject to change based on known risks detailed from time to time in the Company’s Securities and Exchange Commission filings and other known and unknown risks and various other factors which could cause the actual results or performance to differ materially from the statements made herein.
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