HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 — Class II medical device recall Z-1573-2022
Ongoing recall by Mizuho OSI, reported 2022-08-31, distributed nationwide. One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
| Recall number | Z-1573-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mizuho OSI, Union City, CA, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2022-08-24 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13 devices |
| UPC / GTIN / UDI-DI | 00842430106842 |
| Lot numbers | MIZ210712 |
| Model numbers | 6850-144 |
Product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Reason for recall
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
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-1573-2022. 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.