Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD Product Code: H3-82856. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
FDA Recall Z-1984-2009 · Posted 2009-09-10
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Recalling FirmOmni Life Science
Recall StatusTerminated
Product CodeKWY
Date Initiated2009-07-10
Date Terminated2012-06-28
Product Quantity17 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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