Z-0707-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- December 6, 2018
- Termination Date
- December 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.