FDAClass IIDecember 25, 2019

Medtronic Adapter Percutaneous Pin recall

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits…

Why was Medtronic Adapter Percutaneous Pin 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits…
Recalling firm
Medtronic Navigation, Inc.
Quantity
1,297 percutaneous pin adapters
Distribution
Distribution was nationwide. There was government/military/foreign distribution.
Recall date
December 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls