FDA Recall
Terminated
HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah, NJ 07430 A Subsidiary of Stryker Corp.
Recall: Z-0073-2008
·
Initiated August 30, 2007
Recall
- Recall Number
- Z-0073-2008
- Event Number
- 44780
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- MEH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 30, 2007
- Posted
- October 25, 2007
- Terminated
- September 5, 2008
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002
Description
HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah, NJ 07430 A Subsidiary of Stryker Corp.
Reason
Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.
Action
Recall notification letters were sent out on August 30, 2007 with return receipt.
Distribution
Product was distributed nationwide and one unit to Brazil.
Quantity
142 units