Oct 1 Zimmer Holdings Inc said it
received a warning letter from the U.S. Food and Drug
Administration citing problems with manufacturing and testing
processes for artificial hip devices made at the company's
Ponce, Puerto Rico, plant.
The warning letter, dated Sept. 19, does not restrict
production or shipment of the hip devices, called Trilogy
Acetabular Systems, or require withdrawal of any products from
the market, Zimmer said in a regulatory filing.
The FDA said Zimmer failed to implement a testing mechanism
to demonstrate the products met certain design specifications
and had not validated the effects of manufacturing operations on
products that incorporate metallic spikes.
The warning follows a June inspection of the company's Ponce
plant. Zimmer said it temporarily suspended release of the
affected products and has since completed the validation process
for Trilogy products that do not incorporate metallic spikes.
The company expects to complete validation of Trilogy spiked
products within the next few weeks.