Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemente
FDA device recall Z-0773-2013 · posted 2013-02-04 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
- Action taken
- Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 275,952 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan,
- Date initiated
- 2012-09-14
- Date posted
- 2013-02-04
- Date terminated
- 2014-06-20
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY ACETABULAR SYSTEM (K934765) | Zimmer, Inc. | 1994-04-29 |