U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
조치
Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.
Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.
제품 설명
Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. || Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.