Recall Z-1938-2018— Ad-Tech Medical Instrument Corporation
Class II · Terminated
Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2017-12-20, terminated 2018-10-12. FDA's recall record names no specific 510(k) clearance for this event. 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 stereotactic frame.. Reason: There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa..
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-20
- Terminated
- 2018-10-12
- Firm location
- Oak Creek, WI, United States
Product description
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 stereotactic frame.
Reason for recall
There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
Data sourced from openFDA. This site is unofficial and independent of the FDA.