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Terminated

Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030

FDA Recall Z-0696-03 · Posted 2003-04-01

Recalling FirmMitek Worldwide
Recall StatusTerminated
Product CodeHWC
Date Initiated2003-02-28
Date Terminated2004-02-04
Product Quantity4

Reason for Recall

Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.

Firm Action

Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.

Root Cause

Other

Distribution Pattern

CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933738M. KUROSAKA INTERFERENCE FIXATION SCREWDepuy, Inc. · 1994-02-23

Official Source

View FDA Recall →

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

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