Stryker Corporation Recall 95040
Description: 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 following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-020D
Stryker Corporation Recall 95040 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2724-2024 |
| Event ID | 95040 |
| Event Description | 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 following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-020D |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20240904 |
| Device Code Info | GTIN: 07613327501261 Lot Numbers: 22237017 22241017 22334017 23085017 23179017 23213017 24003017 24015017 |
| Center Classification Date | 20240826 |
| Recall Initiation Date | 20240724 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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