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Terminated

Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.

FDA Recall Z-0275-2008 · Posted 2007-11-29

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKXA
Date Initiated2007-09-26
Date Terminated2008-06-04
Product Quantity1

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.

K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbH · 2007-04-26

Official Source

View FDA Recall →

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

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