FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corporation: Qwix 4.3mm Stabilization Screws - 34mm
- Recall number
- Z-1254-2010
- Recalling firm
- Integra LifeSciences Corporation
- Product
- Qwix 4.3mm Stabilization Screws - 34mm
- Status
- Terminated
- Initiated
- 2010-02-08
- Posted
- 2010-04-07
- Terminated
- 2011-10-27
- Reason
- The screws were etched incorrectly as 32mm instead of the correct 34mm length.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned.
- Quantity
- not on file
- Distribution
- Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
- Lot, serial or model codes
- Part Number: 111434SND Lot Number: E6DO
- 510(k) numbers
- ["K050346"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3004608878
- Firm city
- Cincinnati
- Firm state
- OH
- 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