Recall Z-0707-2020 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 006431
| Date | Dec 6, 2018 |
| Status | Terminated |
| Reason | Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure. |
| Root cause | Device Design |
| Action | The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly. |
| Quantity | 1,297 percutaneous pin adapters |
| Distribution | Distribution was nationwide. There was government/military/foreign distribution. |
| 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 |