Recall Z-0698-2024 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
| Date | Jan 10, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On December 6, 2023, Medtronic Navigation, Inc. issued a Urgent: Medical Device Recall Notification via: UPS . Medtronic ask consignees to take the following actions: 1. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form 3. Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and email the completed form to Medtronic at neuro.qual |
| Quantity | 4,235 units |
| 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, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER Medtronic Navigation, Inc., Aug 14, 2013 |