Z-0300-2009

Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw...

Name: Z-0300-2009 Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw...
Creator: Zimmer Inc.
Published: 2008-06-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-06-11 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-02 and 00-6428-028-02. The... on 2008-06-11. The reason FDA records is "When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging". 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-0300-2009
Status: Terminated
Initiated: 2008-06-11
Posted: 2008-11-21
Terminated: 2009-11-10
Recalling firm: Zimmer GmbH
Product: Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-02 and 00-6428-028-02. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.
Quantity in commerce: 49,474 of all products
Distribution: Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
Product codes and lots: All lots.

Product code LZO

K030724Class IIAlumina Ceramic Femoral Heads, 28 and 32 MmZimmer, Inc. / cleared 2003-06-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)