Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD Product Code: H3-82858. Intended for use in combination wi
FDA device recall Z-1986-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- Omni Life Science
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 17 units
- Distribution
- Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
- Date initiated
- 2009-07-10
- Date posted
- 2009-09-10
- Date terminated
- 2012-06-28
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) (K082468) | Omni Life Science, Inc. | 2009-02-18 |