Stryker Corporation: Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing f

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: 3673 units Lot/code info: GTIN: 07613327501193 Lot Numbers: 22228017 22257017 22269017 22276017 23085017 23095017 23157017 23157027 23179017 23179027 23198017 23213017 23221017 23299017 23345017 23345027

UPC codes

07613327501193

Source

Official record: FDA (Device enforcement) ↗

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