Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-040DC

Reason: Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

Code information: GTIN: 07613327501155 Lot Numbers: 22248017 22263017 22334017 22348017 22348027 23016027 23095027 23128017 23163017 23179017 23205017 23205027 23205037 23221017 23311017 24004017 24004027 24004037

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.