Medtronic Navigation, Inc. recalls Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contai…

Recall date

December 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0707-2020

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.