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U.S. Department of Health and Human Services

Class 2 Device Recall Apex Arc Hip Stem, Size 2, HA Coated

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  Class 2 Device Recall Apex Arc Hip Stem, Size 2, HA Coated see related information
Date Initiated by Firm May 09, 2014
Date Posted August 15, 2014
Recall Status1 Terminated 3 on August 19, 2014
Recall Number Z-2241-2014
Recall Event ID 68527
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, Size 2, HA Coated; Product Code: HC-21002-HA
Code Information Lot: 17284
Recalling Firm/
Manufacturer		 Omnilife Science Inc.
50 Oconnell Way Ste 10
East Taunton MA 02718-1394
For Additional Information Contact Matt Nowland
774-226-1841
Manufacturer Reason
for Recall		 Staining on hip implant.
FDA Determined
Cause 2		 Manufacturing material removal
Action All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.
Quantity in Commerce 13 devices
Distribution US: CA, OK, VA, FL, MA, NY, TX
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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