Recall Z-1985-2009 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD Product Code: H3-82857. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
| Date | Sep 10, 2009 (initiated Jul 10, 2009) |
| Status | Terminated |
| Reason | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. |
| Root cause | 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 | 17 units |
| Distribution | Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) Omni Life Science, Inc., Feb 18, 2009 |