FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-1789-2008
- Recalling firm
- Encore Medical, Lp
- Product
- Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
- Status
- Terminated
- Initiated
- 2008-04-11
- Posted
- 2008-09-05
- Terminated
- 2009-01-21
- Reason
- Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.
- 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
- 28 units.
- Distribution
- Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.
- Lot, serial or model codes
- Lot/Serial #209472, 209482, 235192, 276652, 510961 and 964151.
- 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