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U.S. Department of Health and Human Services

Class 2 Device Recall Apex ARC Hip Stem

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  Class 2 Device Recall Apex ARC Hip Stem see related information
Date Initiated by Firm June 03, 2015
Date Posted July 14, 2015
Recall Status1 Terminated 3 on September 08, 2015
Recall Number Z-2064-2015
Recall Event ID 71407
510(K)Number K090845  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA

Product Usage:
The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Code Information Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
Recalling Firm/
Manufacturer		 Omnilife Science Inc.
50 Oconnell Way Ste 10
East Taunton MA 02718-1394
For Additional Information Contact Matthew Nowland
774-226-1841
Manufacturer Reason
for Recall		 Product may breach the inner and outer sterile pouches during shipping or handling.
FDA Determined
Cause 2		 Packaging
Action All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com.
Quantity in Commerce 146 devices
Distribution US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
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 = LZO and Original Applicant = OMNI LIFE SCIENCE, INC.
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