Recall Z-2704-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
| Date | Jun 19, 2017 (initiated Apr 7, 2017) |
| Status | Terminated |
| Reason | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required. |
| Root cause | Process control |
| Action | Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at kaya@exac.com or 800-392-2 |
| Quantity | 9 devices |
| Distribution | CA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150890 | Exactech Optetrak Logic CC Exactech, Inc., May 29, 2015 |