Stryker Corporation: Stryker iBur 2.0mm 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: 1226 units Lot/code info: GTIN: 07613327501261 Lot Numbers: 22237017 22241017 22334017 23085017 23179017 23213017 24003017 24015017

UPC codes

07613327501261

Source

Official record: FDA (Device enforcement) ↗

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