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Terminated

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

FDA Recall Z-2544-2019 · Posted None

Recalling FirmAd-Tech Medical Instrument Corporation
Recall StatusTerminated
Product CodeHBG
Date Initiated2019-08-27
Date Terminated2023-04-05
Product Quantity315 units

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.

Firm Action

The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.

Root Cause

Under Investigation by firm

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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