Recall archive / FDA device enforcement
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile — FDA record Z-0693-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
- Reason
- Products are mislabeled with the incorrect product identification on individual kit labeling.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 50 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0693-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Item No. 8800297010; Lot No. 90328; UDI 10194717113164 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Missouri
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 9, 2022
- Recall initiation date
- Jan 13, 2022
- Center classification date
- Feb 28, 2022
- Termination date
- Sep 28, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.