Integra LifeSciences Corp. QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Catalog number: 111426S, Lot E54Q
Products Sold
Catalog number: 111426S; Lot E54Q
Integra LifeSciences Corp. is recalling QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone frac due to Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026