Z-2544-2019 Class II Terminated
FDA device recall Z-2544-2019 was initiated by Ad-Tech Medical Instrument Corporation on August 27, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 5, 2023). Affected quantity: 315 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2019
- Initiation Date
- August 27, 2019
- Termination Date
- April 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315 units
Product Description
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
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 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
Code Information
All serial numbers distributed between January 2014 and May 2019