Qwix 4.3mm Stabilization Screws - 32mm
FDA device recall Z-1253-2010 · posted 2010-04-07 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corporation
- Reason for recall
- The screws were etched incorrectly as 34mm instead of the correct 32mm.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HWC
- Distribution
- Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
- Date initiated
- 2010-02-08
- Date posted
- 2010-04-07
- Date terminated
- 2011-10-27
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STABILIZATION SCREW (K050346) | New Deal, S.A. | 2005-03-17 |