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

FDA Device Recall #Z-0464-2013 — Class II — June 8, 2012

Recall Summary

Recall Number Z-0464-2013
Classification Class II — Moderate risk
Date Initiated June 8, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merit Medical Systems, Inc.
Location Chester, VA
Product Type Devices
Quantity 83 packs

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.

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.

Distribution Pattern

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

Lot / 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

Other Recalls from Merit Medical Systems, Inc.

Recall # Classification Product Date
Z-1578-2026 Class I DuraMax Chronic Hemodialysis Catheter, REF: H78... Feb 13, 2026
Z-1576-2026 Class I ProGuide Chronic Dialysis Catheters, REF: DC014... Feb 13, 2026
Z-1577-2026 Class I 16F Dual Valved Splittable Sheath Introducer (b... Feb 13, 2026
Z-1575-2026 Class I CentrosFLO Hemodialysis Catheters, REF: CENFP15... Feb 13, 2026
Z-1579-2026 Class I BioFlo DuraMax Catheter, REF: H965103028011/A, ... Feb 13, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.