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

Products are mislabeled with the incorrect product identification on individual kit labeling.

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.