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
Reported: September 25, 2019 Initiated: August 27, 2019 #Z-2544-2019
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.
Details
- Recalling Firm
- Ad-Tech Medical Instrument Corporation
- Units Affected
- 315 units
- 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
- Location
- Oak Creek, WI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ad-Tech Medical Instrument Corporation. Units affected: 315 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2019. Severity: Moderate. Recall number: Z-2544-2019.
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