Recall Z-0809-04 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Centerpulse Orthopedics, Inc
RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
| Date | Jul 20, 2004 (initiated Sep 30, 2003) |
| Status | Terminated |
| Reason | Compalints of acetabular shell disassociating with the bone. |
| Root cause | Other |
| Action | The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory. |
| Quantity | 145 units |
| Distribution | Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022985 | ASCENDENT ACETABULAR SYSTEM Sulzer Orthopedics, Inc., Dec 5, 2002 |