Z-0464-2013Class II

Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A...

Name: Z-0464-2013 Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A...
Creator: Merit Medical Systems, Inc.
Published: 2012-06-08
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2012-06-08 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally... on 2012-06-08. FDA classified it as Class II and gives the reason as "Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0464-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-08
Posted: 2012-12-03
Terminated: 2012-12-10
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Product code: LRO General Surgery Tray
Reason for recall: Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Merit Medical, sent an "URGENT PRODUCT RECALL NOTICE" letter dated June 8, 2012 to its customers by letter sent by US Postal Service - Certified Mail Receipt describing the problem, instructions as to actions that need to be taken, and requesting the customer to complete and sign the Customer Response Form and immediately fax a copy to this form to 1-804-416-1031. Customers were instructed to mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Should the customer choose to return the product for rework, they are to return the affected products by shipping them back to Merit Medical Systems via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department RGA #NC-53417, Merit Medical Systems, Inc., Attn: Manager of Quality Assurance and Regulatory Affairs, 12701 Kingston Ave., Chester, VA 23836. For questions customers were instructed to contact Manager of Quality Assurance and Regulatory Affairs at 1-804-416-1048 or email: [email protected].
Quantity in commerce: 83 packs
Distribution: Nationwide distribution: US including states of: NE and SD.
Product codes and lots: Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

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)