Recall Z-1459-2015 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
| Date | Apr 20, 2015 (initiated Feb 13, 2015) |
| Status | Terminated |
| Reason | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. |
| Root cause | Labeling mix-ups |
| Action | Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice. |
| Quantity | 112 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042021 | EXACTECH EQUINOXE SHOULDER SYSTEM Exactech, Inc., Oct 26, 2004 |