Z-1388-2009

Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The...

Name: Z-1388-2009 Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-01-06
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-01-06 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction... on 2009-01-06. The reason FDA records is "Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1388-2009
Status: Terminated
Initiated: 2009-01-06
Posted: 2009-07-22
Terminated: 2012-06-25
Recalling firm: Howmedica Osteonics Corp
Product: Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Product code: KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Reason for recall: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
Quantity in commerce: 1,628 total stems, all varieties.
Distribution: Nationwide Distribution.
Product codes and lots: Product number: 6046-0425, Lot 24897301 and Product number: 6046-0830, Lot 24352201.

Product code KWL

K920193Class IIOmniflex M-Ha Hip Stem SeriesStryker Corp. / cleared 1992-06-08

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)