Class 2 Device Recall OMNI Hip System, ApeXLNK Acetabular Inserts

• Date Initiated by Firm: May 18, 2018
• Create Date: July 25, 2018
• Recall Status: Terminated 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: 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