Device product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Z-1573-2022
Product summary
- Firm
- Mizuho OSI
- Event
- Event 90603
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 devices
- Official record key
device-enforcement:Z-1573-2022
Official wording
Reason: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Code information: Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Distribution pattern: U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Derived failure modes
-
Unknown
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.