Z-0698-2024 Class II Ongoing
FDA device recall Z-0698-2024 was initiated by Medtronic Navigation, Inc. on November 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4,235 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,235 units
Product Description
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.
Code Information
UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369