Many of Zimmer's orthopedic surgical products (OSP) will go back to production within the next two or three months as Zimmer corrects quality system problems that forced it to stop certain operations in the Dover, OH plant.

According to CEO David Dvorak, remediation plans continue as scheduled as Zimmer expects to have most, if not all, of the OSP products back into production by the end of this year.

The firm halted the manufacture of many patient care products, such as wound debridement kits, at the facility after an FDA inspection identified deficiencies at the plant. The production stoppage is estimated to cost the firm $70 million to $80 million in lost revenue this year.

Chief Financial Officer James Crines does not anticipate getting all of that lost revenue back when the products are relaunched in 2009.

Zimmer has also suspended U.S. sales of its Durom acetabular cups, used for total hip replacements, until the firm revises surgical instructions and retrains physicians. The suspension is expected to cost the company $20 million to $30 million.

Zimmer halted distribution of the cups after examining its manufacturing process and data from more than 3,100 device users in the U.S. and abroad. The investigation revealed incidents of cups loosening and a revision surgery rate of 5.7 percent when they were not placed in a specific manner, or when "crucial technique steps" were not taken.

The company said that there was no evidence of any material, design or manufacture defects. The investigation concluded that surgeons who do not use specific surgical techniques have a lower success rate.

The device is a cobalt-chromium alloy cup designed for use with Zimmer's Metasul Metal-on-Metal Tribological Solution LDH for total hip replacement. It has a titanium plasma-sprayed coating. It was launched in Europe five years ago for hip resurfacing - an alternative to hip replacement - but the FDA has not approved it for that use. It also is available in Canada, Australia, India, Korea and Argentina for hip resurfacing.

In addition, Zimmer has voluntarily recalled a surgical instrument used in minimally invasive knee-implant surgeries.

The company had received reports that some tibial broach impactors, which are used to prepare the tibial bone for an implant, had broken during surgery. Zimmer said other instruments could be used for this purpose.

Zimmer has notified the FDA and affected customers, and it does not expect the recall to materially impact its sales.

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