Recall Z-0582-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
| Date | Jan 18, 2024 (initiated Nov 21, 2023) |
| Status | Open, Classified |
| Reason | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Root cause | Packaging change control |
| Action | Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email. |
| Distribution | US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160484 | Optetrak Advanced Patella Exactech, Inc., Mar 18, 2016 |
| K932690 | EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY Exactech, Inc., Feb 9, 1995 |
| K933610 | EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS Exactech, Inc., Jan 17, 1995 |
| K954208 | OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY Exactech, Inc., Feb 26, 1996 |