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Terminated

Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420

FDA Recall Z-0699-03 · Posted 2003-04-01

Recalling FirmMitek Worldwide
Recall StatusTerminated
Product CodeHWC
Date Initiated2003-02-28
Date Terminated2004-02-04
Product Quantity20

Reason for Recall

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

K982662DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREWDePuy Orthopaedics, Inc. · 1998-10-28

Official Source

View FDA Recall →

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

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