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
This recall has been terminated (originally issued August 27, 2019).
- Recall Initiated
- August 27, 2019
- Terminated
- April 5, 2023
- Recall Number
- Z-2544-2019
- Quantity
- 315 units
- Firm Location
- Oak Creek, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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 / Code Info
All serial numbers distributed between January 2014 and May 2019
Root Cause
Under Investigation by firm
Action Taken
The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.
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