Z-1446-2008

QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or...

Name: Z-1446-2008 QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or...
Creator: Integra LifeSciences Corp.
Published: 2008-02-27
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2008-02-27 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction on 2008-02-27. The reason FDA records is "Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1446-2008
Status: Terminated
Initiated: 2008-02-27
Posted: 2008-08-15
Terminated: 2008-08-21
Recalling firm: Integra LifeSciences Corporation
Product: QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
Product codes and lots: Catalog Number 222428S; Lot E54R

Product code HWC

K050346Class IIStabilization ScrewNew Deal, S.A. / cleared 2005-03-17

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)