FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
- Recall number
- Z-1063-05
- Recalling firm
- Encore Medical, Lp
- Product
- Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
- Status
- Terminated
- Initiated
- 2005-06-08
- Posted
- 2005-08-03
- Terminated
- 2007-04-19
- Reason
- Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
- Root cause
- Other
- Action
- The firm notified all sales agencies and affected products are on return.
- Quantity
- Nationwide including: TX, MS, FL, SC, GA, CA, PA, MA, NJ, MD, OK, MO, AZ, SD, UT, ID
- Distribution
- Nationwide
- Lot, serial or model codes
- Catalog # 400-01-290/291/292/295/296/297 498-28-048
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MRA
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28