Recall Z-1022-2025 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
| Date | Jan 27, 2025 (initiated Dec 4, 2024) |
| Status | Open, Classified |
| Reason | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. |
| Root cause | Under Investigation by firm |
| Action | On 12/04/2024, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day mail to customers to inform them that Medtronic has become aware that certain percutaneous pin lots have been identified as having the potential for an out of round diameter, that may render the percutaneous pin unable to fit into the Patient Reference Frame (9732353) or Percutaneous Pin Adapter (9734752). Customers are instructed to: 1.Immediately locate and quarantine all unused impacted product(s). See Attachment A for affected lot numbers and product identification. 2.Return unused impacted product(s) to |
| Quantity | 67,370 pins |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Aus |
| 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 |