Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0799-06

Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip...

Encore Medical, LP / initiated 2006-01-12 / Terminated

Encore Medical, Lp began a recall of 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... on . The reason FDA records is "Voids in the porous coating of a component used in total hip replacement surgery". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0799-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Encore Medical, LP
Product
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.
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall
Voids in the porous coating of a component used in total hip replacement surgery.
FDA 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 in commerce
Total of 30 units
Distribution
Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
Product codes and lots
Lot numbers 276202 and 270512