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Recall Observatory FDA recall evidence

Device 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.

Z-1938-2018

December 20, 2017

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
Event
Event 80002
Status
Terminated
Classification
Class II
Quantity
30 devices
Official record key
device-enforcement:Z-1938-2018

Official wording

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.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.