Recall Z-0693-2022— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2022-01-13, terminated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-13
- Terminated
- 2022-09-28
- Firm location
- Republic, MO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.