Stryker Corporation: Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 2507 units Lot/code info: GTIN: 7613327501230 Lot Numbers: 22216017 22230017 22334017 23004017 23004027 23009017 23157017 23208017 23233017 23233027 24003017

UPC codes

7613327501230

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.