Z-1063-05

Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement...

Name: Z-1063-05 Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement...
Creator: Encore Medical, Lp
Published: 2005-06-08
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2005-06-08 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries on 2005-06-08. The reason FDA records is "Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1063-05
Status: Terminated
Initiated: 2005-06-08
Posted: 2005-08-03
Terminated: 2007-04-19
Recalling firm: Encore Medical, LP
Product: Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
Product code: MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Reason for recall: Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm notified all sales agencies and affected products are on return.
Quantity in commerce: Nationwide including: TX, MS, FL, SC, GA, CA, PA, MA, NJ, MD, OK, MO, AZ, SD, UT, ID
Distribution: Nationwide
Product codes and lots: Catalog # 400-01-290/291/292/295/296/297 498-28-048

Product code MRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)