Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
FDA device recall Z-1063-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
- Action taken
- The firm notified all sales agencies and affected products are on return.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRA
- Quantity affected
- Nationwide including: TX, MS, FL, SC, GA, CA, PA, MA, NJ, MD, OK, MO, AZ, SD, UT, ID
- Distribution
- Nationwide
- Date initiated
- 2005-06-08
- Date posted
- 2005-08-03
- Date terminated
- 2007-04-19
- Location
- Austin, TX
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