Ad-Tech Drill Sleeve Guides Recalled Due to Raw Material Tolerance Defect
Ad-Tech Medical Instrument Corporation is recalling 65 Drill Sleeve Guides because raw material diameter was under tolerance, which could cause drill bits to seize during surgery.
What this means for you
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 risk-of-harm product where a mechanical failure (drill bit seizing) could occur during surgery, but the source text does not report any actual injuries or illnesses.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 65 units of Drill Sleeve Guides, catalog number DSG-6.3-090-2.4N. These accessories are used with Ad-Tech Cranial Drill Bits for drilling holes in the skull during neurological procedures, such as brain biopsies and electrode placement.
The recall was initiated because the diameter of the raw material used in the guides was found to be under tolerance. This defect potentially results in the drill bit seizing in the guide during surgery. The affected products were distributed nationwide in the United States to the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, and WV, as well as worldwide to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected products immediately. The specific lot numbers involved are 107104, 114390, 111423, 105176, 113775, 115847, 113776, 115000, 114724, 116389, and 117146. Users should contact Ad-Tech Medical Instrument Corporation for instructions on returning the recalled items.
The recalled product
- Product
- AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cra
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Affected units
- 65
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 (11)
- Catalog Number DSG-6.3-090-2.4N. Batch Number (Lot Number): 107104 (710220)
- 114390 (715001)
- 111423 (716180)
- 105176 (613121)
- 113775 (719190)
- 115847 (712211)
- 113776 (719190)
- 115000 (714201)
- 114724 (711101)
- 116389 (712121)
- 117146 (810110).
Distribution
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