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Recall Observatory FDA recall evidence

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

August 27, 2019

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
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

    reason.no_named_rule · v1.0.0

    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.