Recall Z-0302-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-01 and 00-6428-032-01. 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, co
| Date | Nov 21, 2008 (initiated Jun 11, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030724 | ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM Zimmer, Inc., Jun 3, 2003 |