FDAFDA · Food and drugs·Recall number Z-2017-2017
45 degree Contra Angle Attachment Product Usage: Pneumatic system
Published May 10, 2017 · Recall initiated: October 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Supplied Directions for Use (DFU) did not contain a recommended service interval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
- Lot
- All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-45.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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