FDA Medical Device Recalls (openFDA)
Omni Life Science: 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.
- Recall number
- Z-1984-2009
- Recalling firm
- Omni Life Science
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-07-10
- Posted
- 2009-09-10
- Terminated
- 2012-06-28
- 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.
- Lot, serial or model codes
- Lot Number: 5221
- 510(k) numbers
- ["K082468"]
- PMA numbers
- not on file
- Product code
- KWY
- Firm FEI
- 3008342029
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28