Ad-Tech Medical Recalls Disposable Drill Kits Due to Potential Component Mix-Up
Ad-Tech Medical Instrument Corporation is recalling 30 sterile Disposable Drill Kits because they may contain drill bits from the wrong catalog number.
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 (medical device) where the use of incorrect drill bit sizes could lead to injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 30 units of sterile, single-use Disposable Drill Kits. The affected products include catalog numbers DDK2-2.4-30X and DDK2-2.8-30X. These kits are used to drill cranial holes using a stereotactic frame and contain two drill bits, two drill stops, and two adjustment wrenches.
The recall was initiated because there is a possibility that the DDK2-2.4-30X kits contained 2.8mm drill bits from the DDK2-2.8-30X kits, and vice versa. This mix-up could result in the use of incorrect drill bit sizes during surgical procedures.
The affected devices were distributed nationwide in the United States to California, the District of Columbia, Florida, Michigan, Massachusetts, North Carolina, New York, Washington, and Wisconsin. They were also distributed to Canada and the United Kingdom. Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a ste
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Affected units
- 30
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 (6)
- Catalog No. DDK2-2.4-30X
- Lot No. 0111664 208140649
- UDI No. 01008418231011741719080110011174 5208140649
- Catalog No. DDK2-2.8-30X
- Lot No. 0111745 208140649
- UDI No. 01008418231011671719080110011166 4208140649
Distribution
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