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Terminated

Qwix 4.3mm Stabilization Screws - 34mm

FDA Recall Z-1254-2010 · Posted 2010-04-07

Recalling FirmIntegra LifeSciences Corporation
Recall StatusTerminated
Product CodeHWC
Date Initiated2010-02-08
Date Terminated2011-10-27

Reason for Recall

The screws were etched incorrectly as 32mm instead of the correct 34mm length.

Firm Action

Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050346STABILIZATION SCREWNew Deal, S.A. · 2005-03-17

Official Source

View FDA Recall →

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

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