—#69092

Product

QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K050346
Affected lot / code info: Catalog number: 111426S; Lot E54Q

Why it was recalled

Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution --- including states of NC, IL, CA, NC and TX.

Timeline

Recall initiated: 2008-02-27
Posted by FDA: 2008-08-15
Terminated: 2008-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69092. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.