Recall Z-1573-2022 ยท LXH Orthopedic Manual Surgical Instrument
Mizuho OSI
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
| Date | Jul 29, 2021 |
| Status | Open, Classified |
| Reason | One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number. |
| Root cause | Process control |
| Action | On or about 07/05/2022, Muzuho OSI Representative started visiting customers to inform them of a labeling error with the Femur Hook, Right 6850-918 which was incorrectly label with part number 6850-144. Mizuho Representatives were instructed to inform customers: -Over this summer, their facility should have received a Classic Femur Hook, Right 6850-144, either as part of your Hana Table purchase or as a replacement part. But, in error, may have received the other style of femur hook mislabeled with the part number 6850-144. -Hand deliver the Customer Notification Letter and Acknowledge Form. |
| Quantity | 13 devices |
| Distribution | U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.