The product was distributed nationally to 8 consignees and internationally to 12 consignees via distributors and directly to physicians and/or medical facilities. Foreign countries include, Canada, Poland and Italy. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and medical facilities who received the recalled product.
Description du dispositif
Biosteon brand HA/PLLA Cross Pin, || Model Number 234-500-350; || Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138