Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF
FDA device recall Z-0304-2009 · posted 2008-11-21 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 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,
- Date initiated
- 2008-06-11
- Date posted
- 2008-11-21
- Date terminated
- 2009-11-10
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM (K030724) | Zimmer, Inc. | 2003-06-03 |