Ad-Tech Medical Instrument Corporation recalls Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bi…

Recall date

December 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1938-2018

FDA classification

Class II

Brand / firm

Ad-Tech Medical Instrument Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.