Class 2 Device Recall OMNI K1 Broach Handle

• Date Initiated by Firm: November 29, 2018
• Create Date: February 14, 2019
• Recall Status: Terminated on April 16, 2020
• Recall Number: Z-0837-2019
• Recall Event ID: 81951
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: OMNI K1 Broach Handle, Product Code HS-10054
• Code Information: Lot Number MM0118
• Recalling Firm/ Manufacturer: OMNIlife science Inc.; 480 Paramount Dr; Raynham MA 02767-1085
• For Additional Information Contact: Christina Rovaldi; 774-226-1857
• Manufacturer Reason for Recall: There is a potential for the inner pin of the handle to become loose and fall out.
• FDA Determined Cause: Under Investigation by firm
• Action: Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18.
• Quantity in Commerce: 7
• Distribution: The products were distributed to the following US states: CA, GA, SC, and UT.
• 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.