Z-1786-2008

Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore...

Name: Z-1786-2008 Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore...
Creator: Encore Medical, Lp
Published: 2008-04-11
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2008-04-11 / Terminated

FDA source

Encore Medical, Lp began a recall of Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758 on 2008-04-11. The reason FDA records is "Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1786-2008
Status: Terminated
Initiated: 2008-04-11
Posted: 2008-09-05
Terminated: 2009-01-21
Recalling firm: Encore Medical, LP
Product: Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Product code: MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Reason for recall: Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.
FDA root cause: Other
Action: An Urgent: Medical Device Recall letter was issued by the firm on 04/11/08. Consignees were told that they did not have marketing approval for the Polyethylene Backup Liner (poly liner) for use with the Keramos Ceramic-on-Ceramic Acetabular System. Therefore, they are removing it from the market while pursuing marketing approval.
Quantity in commerce: 41 units
Distribution: Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.
Product codes and lots: Lot/Serial #209412, 209422, 235172, 276622, 467701 and 964121.

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)