Device product
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Z-0693-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 kits
- Official record key
device-enforcement:Z-0693-2022
Official wording
Reason: Products are mislabeled with the incorrect product identification on individual kit labeling.
Code information: Item No. 8800297010; Lot No. 90328; UDI 10194717113164
Distribution pattern: Missouri
Derived failure modes
-
Labeling or packaging
mislabeled