Recall Z-2204-2019 ยท GZL Electrode, Depth
Ad-Tech Medical Instrument Corporation
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bo
| Date | Jun 18, 2019 |
| Status | Terminated |
| Reason | On 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 anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts. |
| Root cause | Employee error |
| Action | Ad-Tech Medical notified customers on about 06/18/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were instructed to immediately examine inventory and quarantine any parts subject to the recall, notify all customers if the affected parts have been further distributed, and provide a copy of the recall notification letter. Additionally, customers were instructed to complete and return the customer response form, contact Ad-Tech Customer Support Specialists to obtain a Return Material Authorization (RMA) number, and return all affected parts to Ad-Tech Medical Instrument Corporation |
| Quantity | 201 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation, Aug 9, 2018 |