Recall Z-0579-2024 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
| 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
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM Exactech, Inc., Feb 23, 2007 |
| K093275 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER Exactech, Inc., May 27, 2010 |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System Exactech, Inc., Jul 25, 2018 |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equ Exactech, Inc., Oct 12, 2018 |