Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK — Class II medical device recall Z-2008-2012
Terminated recall by DeRoyal Industries Inc, reported 2012-07-25, distributed nationwide. Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is inten
| Recall number | Z-2008-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2012-06-16 |
| Classified | 2012-07-13 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-11-09 |
| Distributed | Nationwide (US) |
| Quantity | 303 units |
| Lot numbers | 22737521, 22924079, 22924204, 23427293, 23536123, 23623163, 23880637, 24076552, 24076691, 24162522, 24295421, 24435084, 24585728, 24600836, 24750543, 24900118, 25030484, 25088133, 25144351, 25275511, 25461743, 25559311, 25598563, 26021993, 26064301, 26476576, 26924324, 26959148, 27264233, 27526176, 27526328, 27756781, 28238361, 28262740, 28481694 |
| Model numbers | 89-6664.03, 89-6664.04 |
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
Reason for recall
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.
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-2008-2012. 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.