Recall Z-2544-2019— Ad-Tech Medical Instrument Corporation
Class II · Terminated
Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2019-08-27, terminated 2023-04-05. It names one FDA 510(k) clearance: K170442. 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: 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..
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-27
- Terminated
- 2023-04-05
- Firm location
- Oak Creek, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.