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U.S. Department of Health and Human Services

Class 2 Device Recall OMNI Hip System, ApeXLNK Acetabular Inserts

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  Class 2 Device Recall OMNI Hip System, ApeXLNK Acetabular Inserts see related information
Date Initiated by Firm May 18, 2018
Create Date July 25, 2018
Recall Status1 Terminated 3 on January 28, 2019
Recall Number Z-2540-2018
Recall Event ID 80406
510(K)Number K101976  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836

Product Usage:
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed
Code Information Lot Numbers - 29147, 29148 & 29778
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact Christina Rovaldi
774-226-1847
Manufacturer Reason
for Recall		 The Internal packaging, the pouch and patient labels are improperly labeled.
FDA Determined
Cause 2		 Employee error
Action On May 18, 2108, all US Agents holding the affected inventory were notified via telephone. On May 23, 2018, OMNILife Science, Inc. issued URGENT MEDICAL DEVICE NOTICES to their customers advising them that the product is being recalled, should be quarantined and returned for repackaging. For questions call 774-226-1847 or 800-448-6664.
Quantity in Commerce 16 units
Distribution US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
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.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = OMNI LIFE SCIENCE, INC.
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