Z-0693-2022 Class II Terminated
FDA device recall Z-0693-2022 was initiated by ROi CPS LLC on Jan 13, 2022 and is designated Class II. Reason for recall: Products are mislabeled with the incorrect product identification on individual kit labeling. The recall status is terminated (terminated Sep 28, 2022). Affected quantity: 50 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Jan 13, 2022
- Termination Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 kits
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.
Distribution Pattern
Missouri
Code Information
Item No. 8800297010; Lot No. 90328; UDI 10194717113164
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0693-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026