Ad-Tech Drill Sleeve Guides Recalled for Potential Drill Bit Seizure
Ad-Tech Medical Instrument Corporation is recalling specific Drill Sleeve Guides because the inner diameter was under tolerance, which could cause the drill bit to seize during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (drill bit seizing) during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 315 units of AD-TECH Drill Sleeve Guides, specifically reference numbers DSG-90-2.3N and DSG-6.3-090-2.4N. These guides are used with Ad-Tech Placement Kits. The recall covers all serial numbers distributed between January 2014 and May 2019.
The recall was initiated because the inner diameter of the drill sleeve guide raw material was found to be under tolerance. This defect potentially results in the drill bit seizing in the guide during surgery.
The affected units were distributed in the United States (including NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, and MD) and internationally in India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil, UK, Spain, Czech Republic, and France. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- 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
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Affected units
- 315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers distributed between January 2014 and May 2019
Distribution
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