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.
FDA Recall Z-0073-2008 · Posted 2007-10-25
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2007-08-30
Date Terminated2008-09-05
Product Quantity142 units
Reason for Recall
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.
Firm Action
Recall notification letters were sent out on August 30, 2007 with return receipt.
Root Cause
Process control
Distribution Pattern
Product was distributed nationwide and one unit to Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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