Recall Z-1253-2010 ยท HWC Screw, Fixation, Bone
Integra LifeSciences Corporation
Qwix 4.3mm Stabilization Screws - 32mm
| Date | Apr 7, 2010 (initiated Feb 8, 2010) |
| Status | Terminated |
| Reason | The screws were etched incorrectly as 34mm instead of the correct 32mm. |
| 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. |
| Distribution | Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050346 | STABILIZATION SCREW New Deal, S.A., Mar 17, 2005 |