Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.
FDA Recall Z-0587-03 · Posted 2003-02-27
Advertisement
Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeJDI
Date Initiated2003-01-07
Date Terminated2003-07-31
Product Quantity136
Reason for Recall
Some components have disassociated post-operatively resulting in additional surgery to the patient.
Firm Action
Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.
Root Cause
Other
Distribution Pattern
The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
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.
Advertisement