FDA recall Z-2544-2019

Ad-Tech Medical Instrument Corporation · Class II · 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

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

Key facts

Status: Terminated
Initiation date: 2019-08-27
Report date: 2019-09-25
Termination date: 2023-04-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Oak Creek, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2019