Food, drugs, devices › Medtronic Navigation, Inc.
Device recall: Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA enforcement event 93611 is a device recall by Medtronic Navigation, Inc. of Lafayette, CO, initiated 28 Nov 2023 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Navigation, Inc. has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Navigation, Inc., Lafayette, CO.
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
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0698-2024 | Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS | 4,235 units | Class II | Ongoing | 17 Jan 2024 |
| Z-0699-2024 | Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS | 4,224 | Class II | Ongoing | 17 Jan 2024 |
Context
Other enforcement events for Medtronic Navigation, Inc.
All 44 events for Medtronic Navigation, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.