Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708.
FDA Recall Z-0276-2008 · Posted 2007-11-29
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKXA
Date Initiated2007-09-26
Date Terminated2008-06-04
Product Quantity5
Reason for Recall
Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
Firm Action
Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
Root Cause
Packaging process control
Distribution Pattern
Nationwide
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.