Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches,...
FDA Recall #Z-1938-2018 — Class II — December 20, 2017
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.
Recalling Firm
Ad-Tech Medical Instrument Corporation — Oak Creek, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
30 devices
Distribution
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.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated