Z-1938-2018Class II

Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile...

Name: Z-1938-2018 Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile...
Creator: Ad-Tech Medical Instrument Corporation
Published: 2017-12-20
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2017-12-20 / Terminated / root cause: packaging

FDA source

Ad-Tech Medical Instrument Corporation began a recall of 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... on 2017-12-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1938-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-05-25
Terminated: 2018-10-12
Recalling firm: AD-Tech Medical Instrument Corp.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Ad-Tech Medical Instrument Corporation, sent a "MEDICAL DEVICE RECALL" letter on approximately 12/20/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine inventory and quarantine any affected product on hand; notify customers of the recall if affected product was further distributed; complete and return the Acknowledgement and Receipt Form via Fax to: 262-634-5668, Attention Customer Support; Mail to: AD-TECH MEDICAL INSTRUMENT CORPORATION, 1901 WILLIAM STREET, RACINE, WI 53404 or Email to: [email protected], and contact an Ad-Tech Customer Support Specialist for a Return Material Authorization (RMA) number. If you have any further questions, contact Regulatory Team Representative and CAPA/Complaints Manager, Monday through Friday, 7:00 AM to 5:00 PM, Central Time via FAX: 262-634-5668, Toll Free: 1-800-776-1555 or Email: [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1938-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1938-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)