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Recall Observatory FDA recall evidence

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.

Z-0707-2020

December 06, 2018

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 84045
Status
Terminated
Classification
Class II
Quantity
1,297 percutaneous pin adapters
Official record key
device-enforcement:Z-0707-2020

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.