Z-1573-2022 Class II Ongoing
FDA device recall Z-1573-2022 was initiated by Mizuho OSI on Jul 29, 2021 and is designated Class II. Reason for recall: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number. The recall status is ongoing. Affected quantity: 13 devices.
Recall details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Jul 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
Product description
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.
Distribution pattern
U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Code information
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1573-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026