Stryker iBur 4 recalled over fire hazard

Recall date

July 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Corporation recalls Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,…

Recall number

Z-2728-2024

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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