The Food & Drug Administration issued a Class I recall of an ear implant made by Olympus (OTC:OCPNY) subsidiary Gyrus AMCI, after some of the product was shipped without being sterilized.
The recall covers only a single lot (lot no. MH136952) of the Micron Bobbin Vent Tube T, 1.27mm, made Dec. 17, 2009, and shipped Dec. 22 by Southborough, Mass.-based Gyrus.
The company called or visited customers Jan. 4 to inform them of its own, voluntary recall and sent a follow-up letter Jan. 27 with an explanation of the problem and instructions for returning the vent tubes, according to the FDA.
A Gyrus spokesman did not immediately return a call seeking comment on the number of implants affected by the recall.
Class I recalls are the watchdog agency’s most severe, for products that could cause serious injury or death.