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Terminated

Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.

FDA Recall Z-1786-2008 · Posted 2008-09-05

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeMRA
Date Initiated2008-04-11
Date Terminated2009-01-21
Product Quantity41 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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