FDA recall Z-0707-2020

Medtronic Navigation, Inc. · Class II · device

Product

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

Distribution was nationwide. There was government/military/foreign distribution.

Key facts

Status: Terminated
Initiation date: 2018-12-06
Report date: 2019-12-25
Termination date: 2020-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0707-2020