FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
- Recall number
- Z-0693-2022
- Recalling firm
- ROi CPS LLC
- Product
- Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
- Status
- Terminated
- Initiated
- 2022-01-13
- Posted
- not on file
- Terminated
- 2022-09-28
- Reason
- Products are mislabeled with the incorrect product identification on individual kit labeling.
- Root cause
- Under Investigation by firm
- Action
- 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 lacy.stewart@roiscs.com so product return can be arranged.
- Quantity
- 50 kits
- Distribution
- Missouri
- Lot, serial or model codes
- Item No. 8800297010; Lot No. 90328; UDI 10194717113164
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28