Z-1988-2009

Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD

Name: Z-1988-2009 Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD
Creator: Omni Life Science
Published: 2009-07-10
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2009-07-10 / Terminated / root cause: design

FDA source

Omni Life Science began a recall of Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD Product Code: H3-82860. Intended for use in combination with an Apex Hip System femoral for... on 2009-07-10. The reason FDA records is "The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1988-2009
Status: Terminated
Initiated: 2009-07-10
Posted: 2009-09-10
Terminated: 2012-06-28
Recalling firm: Omni Life Science, Inc.
Product: Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD Product Code: H3-82860. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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.
Root cause tag: design
FDA 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 in commerce: 17 units
Distribution: Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
Product codes and lots: Lot Number: 5127

Product code KWY

K082468Class IIApex 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. / cleared 2009-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)