Z-0707-2020Class II

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN...

Name: Z-0707-2020 Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN...
Creator: Medtronic Navigation, Inc.
Published: 2018-12-06
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2018-12-06 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set... on 2018-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0707-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-06
Posted: 2019-12-19
Terminated: 2020-12-17
Recalling firm: Medtronic Navigation, Inc
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.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly.
Quantity in commerce: 1,297 percutaneous pin adapters
Distribution: Distribution was nationwide. There was government/military/foreign distribution.
Product codes and lots: Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0707-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0707-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code OLO

K131425Class IINavigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. / cleared 2013-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)