Recall Z-1081-2019 ยท KIH Dispenser, Cement
Zimmer Biomet, Inc.
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
| Date | Feb 28, 2019 |
| Status | Terminated |
| Reason | Lack of an adequate sterilization validation |
| Root cause | Process design |
| Action | Zimmer Biomet issued recall letter on 2/28/19 via FedEx and email identifying reason for recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Surgeons provided with a letter that identifies the issue and their responsibilities, whi |
| Quantity | 89 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033280 | DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM Biomet, Inc., Dec 19, 2003 |