Recall Z-1657-2020 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
| Date | Apr 3, 2020 (initiated Feb 26, 2020) |
| Status | Terminated |
| Reason | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Root cause | Process control |
| Action | On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots. |
| Quantity | 230,001 |
| Distribution | Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Miss |
| FDA record | Open on fda.gov |