Z-0693-2022Class II

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

Name: Z-0693-2022 Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Creator: ROi CPS LLC
Published: 2022-01-13
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-01-13 / Terminated / root cause: labeling and UDI

FDA source

ROi CPS LLC began a recall of Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile on 2022-01-13. FDA classified it as Class II and gives the reason as "Products are mislabeled with the incorrect product identification on individual kit labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0693-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-13
Posted: 2022-02-28
Terminated: 2022-09-28
Recalling firm: ROi CPS LLC
Product: Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Product code: OJH Orthopedic Tray
Reason for recall: Products are mislabeled with the incorrect product identification on individual kit labeling.
Root cause tag: labeling and UDI
FDA 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 [email protected] so product return can be arranged.
Quantity in commerce: 50 kits
Distribution: Missouri
Product codes and lots: Item No. 8800297010; Lot No. 90328; UDI 10194717113164

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0693-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0693-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)