Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
FDA Recall Z-1448-04 · Posted 2004-09-14
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2004-08-03
Date Terminated2004-09-13
Reason for Recall
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
Firm Action
Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
Root Cause
Other
Distribution Pattern
Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
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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