Merit Medical Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0464-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 8, 2012

Date Posted: December 12, 2012

Recall Number: Z-0464-2013

Event ID: 62749

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.

Status: Terminated

Product Quantity: 83 packs

Code Information:

Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092

Distribution Pattern:

Nationwide distribution: US including states of: NE and SD.

Voluntary or Mandated:

Voluntary: Firm initiated