Custom Procedural Trays: Merit's Custom Total Hip Pack — Class II medical device recall Z-0464-2013
Terminated recall by Merit Medical Systems, Inc., reported 2012-12-12, distributed nationwide. Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is i
| Recall number | Z-0464-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., Chester, VA, United States |
| Recall initiated | 2012-06-08 |
| Classified | 2012-12-03 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2012-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 83 packages |
| Lot numbers | T320054, T320059, T331364, T331365, T335090, T335092 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0464-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.