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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Tray

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  Class 2 Device Recall Orthopedic Tray see related information
Date Initiated by Firm January 13, 2022
Create Date February 28, 2022
Recall Status1 Terminated 3 on September 28, 2022
Recall Number Z-0693-2022
Recall Event ID 89471
Product Classification Orthopedic tray - Product Code OJH
Product Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Code Information Item No. 8800297010; Lot No. 90328; UDI 10194717113164
Recalling Firm/
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Lacy Stewart
Manufacturer Reason
for Recall
Products are mislabeled with the incorrect product identification on individual kit labeling.
FDA Determined
Cause 2
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 in Commerce 50 kits
Distribution Missouri
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.