GS0008 2Y — Class II medical device recall Z-0070-2024
Ongoing recall by ROi CPS LLC, reported 2023-10-11, distributed in MO. Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints re
| Recall number | Z-0070-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2023-09-11 |
| Classified | 2023-10-05 |
| Reported by FDA | 2023-10-11 |
| Distributed | MO |
| Quantity | 103 kits |
| UPC / GTIN / UDI-DI | 10194717113805 |
| Lot numbers | 97289 |
| Model numbers | 880082025 |
| Expiration dates | 2025-07-16 |
Product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Reason for recall
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
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-0070-2024. 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.