Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
Brand
Omni Life Science
Lot Codes / Batch Numbers
Lot NUmber :5147
Products Sold
Lot NUmber :5147
Omni Life Science is recalling Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended for due to The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026