Reported Aug 1, 2018 · Terminated
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the…
Ad-Tech Medical Instrument Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ad-Tech Medical Instrument Corporation · 400 W Oakview Pkwy · Oak Creek, WI · 53154-7213
Is this the product you have?
- 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 UsageThe drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter
- Lot codes and dates
- 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)
- Amount recalled
- 65 Total
Where it was sold
Why it was recalled
The 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.
This product could cause temporary or reversible health problems — stop using it.
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