Recall Z-0980-2018 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Zimmer Biomet, Inc.
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
| Date | Dec 8, 2017 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box. |
| Root cause | Under Investigation by firm |
| Action | On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071. |
| Quantity | 12 |
| Distribution | US Nationwide in the states of MN, NJ, CA, TX, ND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS Biomet Manufacturing Corp, May 30, 2006 |