FDA recall Z-0693-2022
ROi CPS LLC · Class II · device
Product
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Reason for recall
Products are mislabeled with the incorrect product identification on individual kit labeling.
Distribution
Missouri
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-13
- Report date
- 2022-03-09
- Termination date
- 2022-09-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2022