FDAFDA · Food and drugs·Recall number Z-2544-2019
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Published September 25, 2019 · Recall initiated: August 27, 2019
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
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Distributor
- NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France
- Lot
- All serial numbers distributed between January 2014 and May 2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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