regard Item Number: 880331 — Class II medical device recall Z-0084-2016
Terminated recall by Resource Optimization & Innovation Llc, reported 2015-10-14, distributed in LA, MS, TX. The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
| Recall number | Z-0084-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation Llc, Springfield, MO, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-10-07 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2017-03-28 |
| Distributed | LA, MS, TX |
| Quantity | 40 kits |
| Reason classes | sterility |
| Lot numbers | 20197, 22095, 23379 |
| Model numbers | 880331 |
Product
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Reason for recall
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
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-0084-2016. 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.