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

• Date Initiated by Firm: May 09, 2014
• Date Posted: August 15, 2014
• Recall Status: Terminated 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
• FEI Number: 3008342029
• 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: 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