Recall Z-1938-2018 ยท LXH Orthopedic Manual Surgical Instrument
Ad-Tech Medical Instrument Corporation
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.
| Date | Dec 20, 2017 |
| Status | Terminated |
| 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. |
| 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: customersupport |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.