Qwix 4.3mm Stabilization Screws - 32mm
This recall has been terminated (originally issued April 7, 2010).
- Company
- Integra Lifesciences Corporation
- Recall Initiated
- February 8, 2010
- Posted
- April 7, 2010
- Terminated
- October 27, 2011
- Recall Number
- Z-1253-2010
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The screws were etched incorrectly as 34mm instead of the correct 32mm.
Distribution
Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
Lot / Code Info
Part Number: 111432SND Lot Number: E6CZ
Root Cause
Labeling mix-ups
Action Taken
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.
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