Recall Z-0168-2020 ยท LRN Wire, Surgical
Exactech, Inc.
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
| Date | Sep 10, 2019 |
| Status | Terminated |
| Reason | Potential for the wire to fracture at the threads and remain in the glenoid. |
| Root cause | Under Investigation by firm |
| Action | Exactech notified customers of the recall on about 09/10/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that Exactech had received reports of the 3.2mm K-Wire fracturing at the threads and remaining in the glenoid. Instructions included to immediately cease distribution of or use of the product, provide the recall information to accounts that may have the affected product in their possession, identify and quarantine any affected products in inventory, and complete and return the attached Recall Acknowledgement Form and Recall Inventory Response form to Exactech vi |
| Quantity | 158 devices |
| Distribution | US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.