Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use; distributed by Encore Medical, L.P.
FDA device recall Z-1785-2008 · posted 2008-09-05 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MRA
- Quantity affected
- 41 units.
- Distribution
- Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.
- Date initiated
- 2008-04-11
- Date posted
- 2008-09-05
- Date terminated
- 2009-01-21
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.