https://plainrecords.com/brand/ad-tech-medical-instrument/New recalls of Ad-Tech Medical Instrument from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-0219-2025/https://plainrecords.com/recall/device/z-0219-2025/Wed, 30 Oct 2024 00:00:00 +0000Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.https://plainrecords.com/recall/device/z-2494-2021/https://plainrecords.com/recall/device/z-2494-2021/Wed, 29 Sep 2021 00:00:00 +0000Incorrect version of labels were used.https://plainrecords.com/recall/device/z-2544-2019/https://plainrecords.com/recall/device/z-2544-2019/Wed, 25 Sep 2019 00:00:00 +0000The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.https://plainrecords.com/recall/device/z-2406-2019/https://plainrecords.com/recall/device/z-2406-2019/Wed, 04 Sep 2019 00:00:00 +0000Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.https://plainrecords.com/recall/device/z-2396-2019/https://plainrecords.com/recall/device/z-2396-2019/Wed, 04 Sep 2019 00:00:00 +0000An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no…https://plainrecords.com/recall/device/z-2204-2019/https://plainrecords.com/recall/device/z-2204-2019/Wed, 14 Aug 2019 00:00:00 +0000On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile…https://plainrecords.com/recall/device/z-2539-2018/https://plainrecords.com/recall/device/z-2539-2018/Wed, 01 Aug 2018 00:00:00 +0000The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.https://plainrecords.com/recall/device/z-1938-2018/https://plainrecords.com/recall/device/z-1938-2018/Wed, 06 Jun 2018 00:00:00 +0000There 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.https://plainrecords.com/recall/device/z-1503-2016/https://plainrecords.com/recall/device/z-1503-2016/Wed, 27 Apr 2016 00:00:00 +0000Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.https://plainrecords.com/recall/device/z-0106-2015/https://plainrecords.com/recall/device/z-0106-2015/Wed, 29 Oct 2014 00:00:00 +0000The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .https://plainrecords.com/recall/device/z-0892-2013/https://plainrecords.com/recall/device/z-0892-2013/Wed, 13 Mar 2013 00:00:00 +0000The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.