FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
- Recall number
- Z-1446-2008
- Recalling firm
- Integra LifeSciences Corp.
- Product
- QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
- Status
- Terminated
- Initiated
- 2008-02-27
- Posted
- 2008-08-15
- Terminated
- 2008-08-21
- Reason
- Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
- 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
- 20 units
- Distribution
- Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
- Lot, serial or model codes
- Catalog Number 222428S; Lot E54R
- 510(k) numbers
- ["K050346"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28