Medtronic Navigation, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0707-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 6, 2018

Date Posted: December 25, 2019

Recall Number: Z-0707-2020

Event ID: 84045

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.

Status: Terminated

Product Quantity: 1,297 percutaneous pin adapters

Code Information:

Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated