Recall Z-0799-06 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, Lp
Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
| Date | Apr 27, 2006 (initiated Jan 12, 2006) |
| Status | Terminated |
| Reason | Voids in the porous coating of a component used in total hip replacement surgery. |
| Root cause | Other |
| Action | Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians. |
| Quantity | Total of 30 units |
| Distribution | Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950542 | METAL BACKED ACETABULAR COMPONENT Encore Orthopedics, Inc., May 25, 1995 |