Z-0532-2013Class II

Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table...

Name: Z-0532-2013 Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table...
Creator: Medline Industries Inc
Published: 2012-09-20
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2012-09-20 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery... on 2012-09-20. FDA classified it as Class II and gives the reason as "The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0532-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-12-17
Terminated: 2012-12-17
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Product code: LRO General Surgery Tray
Reason for recall: The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medline Industries Inc notified the sole direct account on September 20, 2012 via telephone that the affected custom pack were recalled. Instruction was provided to the staff at the facility not to use the pack until it had been reworked with a sterile back table cover.
Quantity in commerce: 18 packs
Distribution: US (nationwide) in the state of West Virginia
Product codes and lots: Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

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)