Class II — DeRoyal Industries Inc
| Recalling firm | DEROYAL INDUSTRIES, INC. |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Surgical kits and trays contain Stryker Hytrel Togas which were 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. |
| Product | Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits |
| Quantity | 303 units |
| Distribution | Nationwide Distribution including SD and NE. |
| Initiated | 2012-06-16 |
| Classified | 2012-07-13 |
| Terminated | 2012-11-09 |
| Recall number | Z-2008-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DeRoyal Industries Inc (Z-2008-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62457/
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