Device product
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
Z-2544-2019
Product summary
- Event
- Event 83628
- Status
- Terminated
- Classification
- Class II
- Quantity
- 315 units
- Official record key
device-enforcement:Z-2544-2019
Official wording
Reason: 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.
Code information: All serial numbers distributed between January 2014 and May 2019
Distribution pattern: 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
Derived failure modes
-
Unknown
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.