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U.S. Department of Health and Human Services

Class 2 Device Recall APEX Hip System Bipolar Head

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  Class 2 Device Recall APEX Hip System Bipolar Head see related information
Date Initiated by Firm July 10, 2009
Date Posted September 10, 2009
Recall Status1 Terminated 3 on June 28, 2012
Recall Number Z-1981-2009
Recall Event ID 52662
510(K)Number K082468  
Product Classification Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Product Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD
Product Code: H3-82853.

Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
Code Information Lot Number: 5246
Recalling Firm/
Manufacturer		 Omni Life Science
175 Paramont Drive
Raynham MA 02767
Manufacturer Reason
for Recall		 The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
FDA Determined
Cause 2		 Device Design
Action Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
Quantity in Commerce 18 units
Distribution Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
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 = KWY and Original Applicant = OMNI LIFE SCIENCE, INC.
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