Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code: H3-82850. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
This recall has been terminated (originally issued September 10, 2009).
- Company
- Omni Life Science
- Recall Initiated
- July 10, 2009
- Posted
- September 10, 2009
- Terminated
- June 28, 2012
- Recall Number
- Z-1978-2009
- Quantity
- 17 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
Lot / Code Info
Lot Number: 5146
Root Cause
Device Design
Action Taken
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.