Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Navigation, Inc.
- Reason for Recall:
- Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Product Codes/Lot Numbers:
UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0699-2024
Related Recalls
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.