Z-0707-2020 Class II Terminated
FDA device recall Z-0707-2020 was initiated by Medtronic Navigation, Inc. on Dec 6, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Dec 17, 2020). Affected quantity: 1,297 percutaneous pin adapters.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2019
- Initiation Date
- Dec 6, 2018
- Termination Date
- Dec 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,297 percutaneous pin adapters
Product Description
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 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
Reason for Recall
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.
Distribution Pattern
Distribution was nationwide. There was government/military/foreign distribution.
Code Information
Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0707-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026