Z-0702-2019Class II

Presource Kit Total Joint Pack containing a double-wrapped basin component

Name: Z-0702-2019 Presource Kit Total Joint Pack containing a double-wrapped basin component
Creator: Cardinal Health Inc.
Published: 2018-11-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-11-16 / Terminated / root cause: sterility

FDA source

Cardinal Health Inc. began a recall of Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip on 2018-11-16. FDA classified it as Class II and gives the reason as "The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0702-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-16
Posted: 2019-01-09
Terminated: 2019-11-04
Recalling firm: Medtronic, Inc.
Product: Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Product code: LRO General Surgery Tray
Reason for recall: The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: As only one customer is potentially impacted, in the interest of prompt action and notification, a teleconference was held on Friday, November 16, 2018 with the customer to communicate the impending actions. During this teleconference, the customer was informed that an HHE and field corrective action was in-process and that a study was being initiated to determine that their requested packaging configuration was acceptable. The customer also was informed that they should not continue to use the impacted double wrapped basin, and the components contained within, until the study was completed. Cardinal Health is following up on this teleconference with a written notification.
Quantity in commerce: 182 packs
Distribution: US state of Florida
Product codes and lots: Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-09

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)