Recall Z-1789-2008 ยท MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
| Date | Sep 5, 2008 (initiated Apr 11, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.