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
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