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Terminated

Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem

FDA Recall Z-0588-03 · Posted 2003-02-27

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeJDI
Date Initiated2003-01-07
Date Terminated2003-07-31
Product Quantity311

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.

K952970HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESMHowmedica Corp. · 1996-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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