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U.S. Department of Health and Human Services

Class 2 Device Recall OMNI K1 Broach Handle

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  Class 2 Device Recall OMNI K1 Broach Handle see related information
Date Initiated by Firm November 29, 2018
Create Date February 14, 2019
Recall Status1 Terminated 3 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 2		 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.
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