QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
FDA Recall Z-1445-2008 · Posted 2008-08-15
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2008-02-27
Date Terminated2008-08-21
Product Quantity42 units
Reason for Recall
Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.
Firm Action
Integra Reps were sent recall notification with a recall acknowledgement on 2/27/2008. The customers who were shipped affected product were also notified on that date.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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