Recall Z-0698-2024— Medtronic Navigation, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2023-11-28. It names one FDA 510(k) clearance: K131425. Product: Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS. Reason: 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..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Lafayette, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.