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Terminated

Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420

FDA Recall Z-1005-03 · Posted 2003-07-15

Recalling FirmMitek Worldwide
Recall StatusTerminated
Date Initiated2003-06-16
Date Terminated2003-10-22
Product Quantity40

Reason for Recall

Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm

Firm Action

Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.

Root Cause

Other

Distribution Pattern

CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain

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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