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
Enforcement
- Recall Number
- Z-2728-2024
- Event ID
- 95040
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- July 24, 2024
- Classification Date
- August 26, 2024
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711, United States
Description
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
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.
GTIN: 07613327501155 Lot Numbers: 22248017 22263017 22334017 22348017 22348027 23016027 23095027 23128017 23163017 23179017 23205017 23205027 23205037 23221017 23311017 24004017 24004027 24004037
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.
5031 units