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Terminated

Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.

FDA Recall Z-2135-2008 · Posted 2008-09-11

Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2007-07-09
Date Terminated2010-02-03
Product Quantity400 screws

Reason for Recall

Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.

Firm Action

The firm issued a Product Removal notification on 8-9-2007. The notification was reportedly sent by either FAX or e-mail. The firm notified consignees of the issue and gave the consignees the choice of returning the screws. The notification did not include any instructions for a sub-recall. If you have any questions contact Jason Gozdecki at 1-888-627-9957.

Root Cause

Packaging process control

Distribution Pattern

Class III Recall - Worldwide Distribution --- USA including countries of UK and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012655CONGRUENT BONE PLATE SYSTEMAcu Med, Inc. · 2001-11-07K942340CORTICAL BONE SCREWAcu Med, Inc. · 1994-12-05K942341CANNULATED CANCELLOUS BONE SCREWAcu Med, Inc. · 1994-12-05

Official Source

View FDA Recall →

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

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