Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case… recallZ-0693-2022 · ROi CPS LLC · initiated Jan 13, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products are mislabeled with the incorrect product identification on individual kit labeling.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm emailed a recall notification to customers on 01/13/2022 tited "ROi CPS, LLC Recall-Custom Procedure Kit Recall-Kits Containing the Incorrect Product Label." The recall notice states that the reason for recall is due to the individual kits being incorrectly labeled, while the outer box is labeled correctly. The outer box was labeled with Product No. 880297010, while the inner kit bags were labeled as Product No. 880261009. Customers are directed to review their inventory to determine if recalled kits are in stock and quarantine any identified recalled product. The firm instructs customers to open the outer carton to examine the packaging of individual bags for incorrect labeling; do not open sterile barrier packaging. Cases containing the correct inner packaging can be released. Customers are asked to complete the recall response form attached to the recall notification indicating any affected product on hand. Complete forms are to be emailed back to [email protected] so product return can be arranged.
Recall details
- Recall number
- Z-0693-2022
- Status
- Terminated
- Initiated by the company
- Jan 13, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 50 kits
- Product code
- OJH
- Distribution
- Missouri
Product description
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Code information (models, lots, serial numbers)
Item No. 8800297010; Lot No. 90328; UDI 10194717113164
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ OR00452JRoi Cps, LLC · Orthopedic Tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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