Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2544-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-08-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2544-2019
Date of alert
2019-08-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ad-Tech Medical Instrument Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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